Drug and Health Product Submissions Under Review (SUR): New drug submissions completed
This list is current as of: 2025-03-31.
An Excel version of the updated SUR List is available from the Overview page.
| Submission Control Number | Medicinal Ingredient(s) | Therapeutic Area | Year, Month Submission was Accepted into Review | Outcome of Submission (Hyperlinked if applicable)Footnote a | Year, Month Submission Concluded |
|---|---|---|---|---|---|
| 234673 | 5-aminolevulinic acid | Antineoplastic agents | 2020-03 | Issued Notice of Compliance | 2020-09 |
| 259301 | Abaloparatide | Calcium homeostasis | 2022-03 | Cancelled by sponsor | 2023-01 |
| 215268 | Abemaciclib | Antineoplastic agents | 2018-06 | Issued Notice of Compliance | 2019-04 |
| 265223 | Abiraterone acetate, niraparib | Endocrine therapy | 2022-08 | Issued Notice of Compliance under the NOC/c Guidance | 2023-06 |
| 245854 | Abrocitinib | Other dermatological preparations | 2020-12 | Issued Notice of Compliance | 2022-06 |
| 214504 | Acalabrutinib | Antineoplastic agents | 2018-04 | Issued Notice of Compliance | 2019-08 |
| 259246 | Acalabrutinib | Antineoplastic agents | 2022-05 | Issued Notice of Compliance | 2023-02 |
| 209478 | Acetaminophen | Analgesics | 2018-02 | Issued Notice of Compliance | 2018-11 |
| 244695 | Acetaminophen | Analgesics | 2021-04 | Issued Notice of Compliance | 2023-02 |
| 260262 | Acetaminophen, ibuprofen sodium dihydrate | Analgesics | 2022-06 | Issued Notice of Compliance | 2024-02 |
| 234460 | Acetylsalicylic acid, atorvastatin calcium, ramipril | Cardiac therapy | 2020-02 | Cancelled by sponsor | 2021-03 |
| 246758 | Ad26.COV2.s (recombinant) *For use in relation to COVID-19 | Vaccines | 2020-11 | Authorized under Interim Order | 2021-03 |
| 253702 | Ad26.COV2.s (recombinant) *For use in relation to COVID-19 | Vaccines | 2021-07 | Issued Notice of Compliance | 2021-11 |
| 203250 | Adalimumab | Immunosuppressants | 2017-04 | Issued Notice of Compliance | 2018-05 |
| 203292 | Adalimumab | Immunosuppressants | 2017-04 | Issued Notice of Compliance | 2018-05 |
| 230637 | Adalimumab | Immunosuppressants | 2019-10 | Issued Notice of Compliance | 2020-10 |
| 229124 | Adalimumab | Immunosuppressants | 2019-09 | Issued Notice of Compliance | 2020-11 |
| 217314 | Adalimumab | Immunosuppressants | 2018-11 | Issued Notice of Compliance | 2020-11 |
| 235685 | Adalimumab | Immunosuppressants | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 247265 | Adalimumab | Immunosuppressants | 2021-03 | Issued Notice of Compliance | 2021-12 |
| 244990 | Adalimumab | Immunosuppressants | 2021-02 | Issued Notice of Compliance | 2022-01 |
| 271199 | Adapalene, benzoyl peroxide, clindamycin phosphate | Anti-acne preparations | 2023-10 | Issued Notice of Compliance | 2024-08 |
| 251005 | Aducanumab | Other nervous system drugs | 2021-06 | Cancelled by sponsor | 2022-05 |
| 189442 | Alectinib | Antineoplastic agents | 2016-02 | Issued Notice of Compliance under the NOC/c Guidance | 2016-09 |
| 246730 | Alfa 1-proteinase inhibitor (human) | Antihemorrhagics | 2021-01 | Issued Notice of Compliance | 2021-11 |
| 183116 | Alirocumab | Lipid modifying agents | 2015-06 | Issued Notice of Compliance | 2016-04 |
| 226941 | Alpelisib | Antineoplastic agents | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 273683 | Alpha1-proteinase inhibitor (human) | Antihemorrhagics | 2023-05 | Issued Notice of Compliance | 2023-11 |
| 189825 | Alvimopan | Drugs for constipation | 2016-03 | Cancelled by sponsor | 2017-03 |
| 234655 | Amifampridine | Other nervous system drugs | 2020-02 | Issued Notice of Compliance | 2023-01 |
| 232685 | Amifampridine phosphate | Other nervous system drugs | 2020-02 | Issued Notice of Compliance | 2020-07 |
| 235705 | Amisulpride | Psycholeptics | 2020-03 | Cancelled by sponsor | 2021-01 |
| 254440 | Amivantamab | Antineoplastic agents | 2021-07 | Issued Notice of Compliance under the NOC/c Guidance | 2022-03 |
| 211854 | Amlodipine besylate | Calcium channel blockers | 2018-07 | Issued Notice of Compliance | 2019-01 |
| 221964 | Amoxicillin sodium, clavulanic acid | Antibacterials for systemic use | 2019-04 | Issued Notice of Compliance | 2020-01 |
| 266464 | Andexanet alfa | All other therapeutic products | 2022-10 | Issued Notice of Compliance under the NOC/c Guidance | 2023-06 |
| 275936 | Andusomeran *For use in relation to COVID-19 | Vaccines | 2023-06 | Issued Notice of Compliance | 2023-09 |
| 246187 | Anifrolumab | Immunosuppressants | 2020-12 | Issued Notice of Compliance | 2021-11 |
| 212387 | Anthrax antigen filtrate | Vaccines | 2018-02 | Issued Notice of Compliance | 2018-12 |
| 200446 | Anthrax immunoglobulin (human) | Immune sera and immunoglobulins | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 194071 | Antihemophilic factor (human), von Willebrand factor (human) | Antihemorrhagics | 2016-06 | Issued Notice of Compliance | 2018-05 |
| 189709 | Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 2016-01 | Issued Notice of Compliance | 2016-11 |
| 210935 | Antihemophilic factor (recombinant, B-domain deleted, pegylated) | Antihemorrhagics | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 218531 | Antihemophilic factor VIII (recombinant, B-domain truncated), pegylated | Antihemorrhagics | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 211942 | Apalutamide | Endocrine therapy | 2018-01 | Issued Notice of Compliance | 2018-07 |
| 217320 | Apomorphine hydrochloride | Anti-parkinson drugs | 2018-08 | Issued Notice of Compliance | 2020-06 |
| 247924 | Aprotinin | Antihemorrhagics | 2021-02 | Cancelled by sponsor | 2022-02 |
| 286599 | Aripiprazole | Psycholeptics | 2024-07 | Issued Notice of Compliance | 2025-01 |
| 255700 | Asciminib hydrochloride | Antineoplastic agents | 2021-08 | Issued Notice of Compliance | 2022-06 |
| 273065 | Ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate | Drugs for constipation | 2023-07 | Issued Notice of Compliance | 2024-08 |
| 186992 | Ataluren | All other therapeutic products | 2015-09 | Cancelled by sponsor | 2016-03 |
| 217349 | Ataluren | Other drugs for disorders of the musculo-skeletal system | 2018-09 | Cancelled by sponsor | 2019-10 |
| 196843 | Atezolizumab | Antineoplastic agents | 2016-08 | Issued Notice of Compliance under the NOC/c Guidance | 2017-04 |
| 253186 | Atogepant | Analgesics | 2021-07 | Issued Notice of Compliance | 2022-12 |
| 262121 | Atropine sulfate | Ophthalmologicals | 2023-04 | Cancelled by sponsor | 2024-07 |
| 248255 | Avacopan | Immunosuppressants | 2021-05 | Issued Notice of Compliance | 2022-04 |
| 245680 | Avalglucosidase alfa | Other alimentary tract and metabolism products | 2020-11 | Issued Notice of Compliance | 2021-11 |
| 220887 | Avanafil | Urologicals | 2019-06 | Issued Notice of Deficiency - Withdrawal | 2021-10 |
| 278913 | Avapritinib | Antineoplastic agents | 2023-11 | Issued Notice of Compliance | 2024-09 |
| 251688 | Avatrombopag maleate | Antihemorrhagics | 2021-06 | Issued Notice of Compliance | 2023-11 |
| 204052 | Avelumab | Antineoplastic agents | 2017-04 | Issued Notice of Compliance under the NOC/c Guidance | 2017-12 |
| 208742 | Avelumab | Antineoplastic agents | 2017-09 | Issued Notice of Compliance under the NOC/c Guidance | 2018-05 |
| 218389 | Axicabtagene ciloleucel | Antineoplastic agents | 2018-08 | Issued Notice of Compliance | 2019-02 |
| 240668 | Azacitidine | Antineoplastic agents | 2020-07 | Issued Notice of Compliance | 2021-01 |
| 221579 | Bacillus Calmette-Guerin BCG - Strain Russian BCG-I | Immunostimulants | 2018-12 | Issued Notice of Compliance under the NOC/c Guidance | 2020-12 |
| 227361 | Baloxavir marboxil | Antivirals for systemic use | 2019-05 | Issued Notice of Compliance | 2020-02 |
| 193687 | Bamlanivimab *For use in relation to COVID-19 | Antiinflammatory and antirheumatic products | 2016-05 | Issued Notice of Compliance | 2018-08 |
| 244947 | Bamlanivimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2020-10 | Authorized under Interim Order | 2020-11 |
| 253646 | Bamlanivimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-07 | Cancelled by sponsor | 2023-02 |
| 208886 | Belinostat | Antineoplastic agents | 2017-12 | Cancelled by sponsor | 2019-11 |
| 245791 | Belumosudil mesylate | Immunosuppressants | 2021-01 | Issued Notice of Compliance | 2022-03 |
| 254495 | Belzutifan | Antineoplastic agents | 2021-09 | Issued Notice of Compliance | 2022-07 |
| 248962 | Bendamustine hydrochloride | Antineoplastic agents | 2021-03 | Issued Notice of Compliance | 2022-01 |
| 249957 | Bendamustine hydrochloride | Antineoplastic agents | 2021-07 | Issued Notice of Compliance | 2022-05 |
| 204008 | Benralizumab | Immunosuppressants | 2017-04 | Issued Notice of Compliance | 2018-02 |
| 179294 | Bepotastine besilate | Ophthalmologicals | 2015-10 | Issued Notice of Compliance | 2016-07 |
| 252301 | Berotralstat hydrochloride | Other hematological agents | 2021-08 | Issued Notice of Compliance | 2022-06 |
| 203765 | Betamethasone valerate, fusidic acid | Corticosteroids, dermatological preparations | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 227270 | Betula verrucosa extract | Nasal preparations | 2019-06 | Issued Notice of Compliance | 2020-04 |
| 201427 | Bevacizumab | Antineoplastic agents | 2017-02 | Issued Notice of Compliance | 2018-04 |
| 218183 | Bevacizumab | Antineoplastic agents | 2018-08 | Issued Notice of Compliance | 2019-06 |
| 217524 | Bevacizumab | Antineoplastic agents | 2018-08 | Issued Notice of Compliance | 2021-01 |
| 244450 | Bevacizumab | Antineoplastic agents | 2020-11 | Issued Notice of Compliance | 2021-09 |
| 242395 | Bevacizumab | Antineoplastic agents | 2020-10 | Cancelled by sponsor | 2021-09 |
| 237499 | Bevacizumab | Antineoplastic agents | 2020-07 | Issued Notice of Compliance | 2021-11 |
| 247724 | Bevacizumab | Antineoplastic agents | 2021-02 | Issued Notice of Compliance | 2021-11 |
| 247369 | Bevacizumab | Antineoplastic agents | 2021-02 | Issued Notice of Compliance | 2021-11 |
| 258973 | Bevacizumab | Antineoplastic agents | 2022-03 | Issued Notice of Compliance | 2023-01 |
| 203718 | Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2017-09 | Issued Notice of Compliance | 2018-07 |
| 184231 | Bilastine | Antihistamines for systemic use | 2015-06 | Issued Notice of Compliance | 2016-04 |
| 259843 | Bimatoprost | Ophthalmologicals | 2022-02 | Issued Notice of Compliance | 2022-12 |
| 238499 | Bimekizumab | Immunosuppressants | 2021-04 | Issued Notice of Compliance | 2022-02 |
| 237410 | Binimetinib | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 203050 | Bisoprolol fumarate | Beta blocking agents | 2017-07 | Issued Notice of Compliance | 2019-11 |
| 231842 | Bisoprolol fumarate | Beta blocking agents | 2020-05 | Cancelled by sponsor | 2020-09 |
| 232423 | Bivalirudin | Antithrombotic agents | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 181723 | Blinatumomab | Antineoplastic agents | 2015-04 | Issued Notice of Compliance under the NOC/c Guidance | 2015-12 |
| 273611 | Bortezomib | Antineoplastic agents | 2023-07 | Issued Notice of Compliance | 2024-07 |
| 190645 | Botulinum antitoxin, serotypes A, B, C, D, E, F, G | Immune sera and immunoglobulins | 2016-02 | Issued Notice of Compliance | 2016-12 |
| 192684 | Brexpiprazole | Psycholeptics | 2016-04 | Issued Notice of Compliance | 2017-02 |
| 246355 | Brexucabtagene autoleucel | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-06 |
| 210369 | Brigatinib | Antineoplastic agents | 2017-11 | Issued Notice of Compliance under the NOC/c Guidance | 2018-07 |
| 232449 | Brilliant blue G | Ophthalmologicals | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 262030 | Brincidofovir | Antivirals for systemic use | 2022-05 | Issued Notice of Compliance | 2023-12 |
| 183355 | Brivaracetam | Antiepileptics | 2015-05 | Issued Notice of Compliance | 2016-03 |
| 195317 | Brodalumab | Immunosuppressants | 2016-07 | Issued Notice of Compliance | 2018-03 |
| 226224 | Brolucizumab | Ophthalmologicals | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 227232 | Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2019-05 | Issued Notice of Compliance | 2019-11 |
| 220876 | Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2019-06 | Issued Notice of Compliance | 2020-04 |
| 242357 | Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide | Drugs for obstructive airway diseases | 2020-09 | Issued Notice of Compliance | 2021-07 |
| 231224 | Bupivacaine | Anesthetics | 2019-12 | Cancelled by sponsor | 2021-08 |
| 233561 | Bupivacaine, meloxicam | Antiinflammatory and antirheumatic products | 2020-01 | Issued Notice of Compliance | 2022-03 |
| 215660 | Buprenorphine | Other nervous system drugs | 2018-05 | Issued Notice of Compliance | 2018-11 |
| 196428 | Buprenorphine hydrochloride | Other nervous system drugs | 2016-08 | Issued Notice of Compliance | 2017-06 |
| 204746 | Buprenorphine hydrochloride | Other nervous system drugs | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 202774 | Bupropion hydrochloride, naltrexone hydrochloride | Antiobesity preparations, excluding diet products | 2017-04 | Issued Notice of Compliance | 2018-02 |
| 216239 | Burosumab | Drugs for treatment of bone diseases | 2018-06 | Issued Notice of Compliance | 2018-12 |
| 198308 | C1 esterase inhibitor (human) | Other hematological agents | 2016-11 | Issued Notice of Compliance | 2017-09 |
| 280033 | Cabotegravir, cabotegravir sodium | Antivirals for systemic use | 2023-11 | Issued Notice of Compliance | 2024-05 |
| 227315 | Cabotegravir, rilpivirine | Antivirals for systemic use | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 206230 | Cabozantinib | Antineoplastic agents | 2017-07 | Issued Notice of Compliance | 2018-09 |
| 225810 | Caffeine citrate | Psychoanaleptics | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 268282 | Calaspargase pegol | Antineoplastic agents | 2022-11 | Issued Notice of Compliance | 2023-11 |
| 205392 | Calcifediol | Vitamins | 2017-09 | Issued Notice of Compliance | 2018-07 |
| 262870 | Calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate | Other nervous system drugs | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 213303 | Canakinumab | Immunosuppressants | 2018-06 | Cancelled by sponsor | 2018-12 |
| 255032 | Cangrelor tetrasodium | Antithrombotic agents | 2021-11 | Issued Notice of Compliance | 2023-01 |
| 268559 | Cannabidiol | Antiepileptics | 2023-01 | Issued Notice of Compliance | 2023-11 |
| 274859 | Capivasertib | Antineoplastic agents | 2023-06 | Issued Notice of Compliance | 2024-01 |
| 230001 | Caplacizumab | Antithrombotic agents | 2019-08 | Issued Notice of Compliance | 2020-02 |
| 255972 | Capmatinib dihydrochloride | Antineoplastic agents | 2021-09 | Issued Notice of Compliance under the NOC/c Guidance | 2022-05 |
| 248574 | Captopril | Agents acting on the renin-angiotensin system | 2021-04 | Issued Notice of Compliance | 2023-12 |
| 257242 | Carbidopa, levodopa | Anti-parkinson drugs | 2022-04 | Issued Notice of Compliance | 2022-10 |
| 184479 | Carfilzomib | Antineoplastic agents | 2015-07 | Issued Notice of Compliance | 2016-01 |
| 249774 | Cariprazine hydrochloride | Psycholeptics | 2021-06 | Issued Notice of Compliance | 2022-04 |
| 249830 | Casirivimab, imdevimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-02 | Authorized under Interim Order | 2021-06 |
| 256264 | Casirivimab, imdevimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-09 | Cancelled by sponsor | 2024-06 |
| 234610 | Cedazuridine, decitabine | Antineoplastic agents | 2020-01 | Issued Notice of Compliance | 2020-07 |
| 261973 | Cefditoren pivoxil | Antibacterials for systemic use | 2022-07 | Cancelled by sponsor | 2024-03 |
| 189720 | Cefixime | Antibacterials for systemic use | 2016-05 | Issued Notice of Compliance | 2017-10 |
| 218718 | Cemiplimab | Antineoplastic agents | 2018-08 | Issued Notice of Compliance under the NOC/c Guidance | 2019-04 |
| 218145 | Cenegermin | Ophthalmologicals | 2018-08 | Issued Notice of Compliance | 2019-02 |
| 261689 | Cenobamate | Antiepileptics | 2022-07 | Issued Notice of Compliance | 2023-06 |
| 216539 | Cerliponase alfa | Other alimentary tract and metabolism products | 2018-06 | Issued Notice of Compliance | 2018-12 |
| 240337 | Cevimeline hydrochloride | Other nervous system drugs | 2020-09 | Issued Notice of Non-compliance - Withdrawal | 2022-04 |
| 244627 | ChAdOx1-S (recombinant) *For use in relation to COVID-19 | Vaccines | 2020-10 | Authorized under Interim Order | 2021-02 |
| 248651 | ChAdOx1-S (recombinant) *For use in relation to COVID-19 | Vaccines | 2021-01 | Authorized under Interim Order | 2021-02 |
| 253700 | ChAdOx1-S (recombinant) *For use in relation to COVID-19 | Vaccines | Issued Notice of Compliance | 2021-11 | |
| 275762 | Chikungunya virus live-attenuated | Vaccines | 2023-08 | Issued Notice of Compliance | 2024-06 |
| 238994 | Chlormethine | Antineoplastic agents | 2020-08 | Issued Notice of Compliance | 2021-06 |
| 270862 | Chloroprocaine hydrochloride | Anesthetics | 2023-05 | Issued Notice of Compliance | 2024-08 |
| 223801 | Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride | Blood substitutes and perfusion solutions | 2019-06 | Issued Notice of Compliance | 2020-04 |
| 200865 | Cidofovir | Antivirals for systemic use | 2017-04 | Issued Notice of Compliance | 2018-03 |
| 258295 | Cilgavimab, tixagevimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-11 | Issued Notice of Compliance | 2022-04 |
| 240368 | Cilostazol | Antithrombotic agents | 2021-02 | Cancelled by sponsor | 2022-07 |
| 262122 | Ciltacabtagene autoleucel | Antineoplastic agents | 2022-04 | Issued Notice of Compliance under the NOC/c Guidance | 2023-02 |
| 195151 | Cinnarizine, dimenhydrinate | Other nervous system drugs | 2016-09 | Issued Notice of Non-compliance - Withdrawal | 2018-11 |
| 200943 | Cladribine | Immunosuppressants | 2017-02 | Issued Notice of Compliance | 2017-11 |
| 265619 | Clascoterone | Anti-acne preparations | 2022-08 | Issued Notice of Compliance | 2023-06 |
| 193638 | Clozapine | Psycholeptics | 2016-05 | Issued Notice of Compliance | 2016-11 |
| 201114 | Coagulation factor IX (recombinant), pegylated | Antihemorrhagics | 2017-02 | Issued Notice of Compliance | 2017-11 |
| 199705 | Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 182788 | Cobimetinib fumarate | Antineoplastic agents | 2015-04 | Issued Notice of Compliance | 2016-02 |
| 248423 | Colchicine | Antigout preparations | 2021-02 | Issued Notice of Compliance | 2021-08 |
| 248711 | Colchicine *For use in relation to COVID-19 | Antigout preparations | 2021-01 | Cancelled by sponsor | 2021-06 |
| 267120 | Concizumab | Antihemorrhagics | 2022-09 | Issued Notice of Compliance | 2023-03 |
| 267314 | Concizumab | Antihemorrhagics | 2022-09 | Issued Notice of Compliance | 2023-07 |
| 255077 | Copanlisib dihydrochloride | Antineoplastic agents | 2021-08 | Cancelled by sponsor | 2021-12 |
| 246125 | Copper, manganese sulfate, selenious acid, sodium iodide, zinc sulfate | Blood substitutes and perfusion solutions | 2021-03 | Issued Notice of Compliance | 2023-03 |
| 253111 | Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F | Vaccines | 2021-07 | Issued Notice of Compliance | 2022-05 |
| 247042 | Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F | Vaccines | 2021-01 | Issued Notice of Compliance | 2021-11 |
| 281914 | Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotype 33F, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 35B | Vaccines | 2024-01 | Issued Notice of Compliance | 2024-07 |
| 206906 | Crisaborole | Other dermatological preparations | 2017-08 | Issued Notice of Compliance | 2018-06 |
| 257092 | Crisantaspase, recombinant | Antineoplastic agents | 2021-11 | Issued Notice of Compliance | 2022-09 |
| 194580 | Cyclosporine | Ophthalmologicals | 2016-08 | Issued Notice of Non-compliance - Withdrawal | 2018-04 |
| 215813 | Cyclosporine | Ophthalmologicals | 2018-07 | Issued Notice of Compliance | 2018-12 |
| 234677 | Cyclosporine | Ophthalmologicals | 2020-04 | Issued Notice of Compliance | 2021-02 |
| 211635 | Cysteamine hydrochloride | Ophthalmologicals | 2018-02 | Issued Notice of Compliance | 2019-02 |
| 242743 | Cytarabine, daunorubicin | Antineoplastic agents | 2020-11 | Issued Notice of Compliance | 2021-04 |
| 190458 | Daclizumab | Immunosuppressants | 2016-02 | Issued Notice of Compliance | 2016-12 |
| 214572 | Dacomitinib | Antineoplastic agents | 2018-05 | Issued Notice of Compliance | 2019-02 |
| 212390 | Dalbavancin | Antibacterials for systemic use | 2018-03 | Issued Notice of Compliance | 2018-09 |
| 274338 | Danicopan | Other hematological agents | 2023-09 | Issued Notice of Compliance | 2024-07 |
| 263001 | Daprodustat | Antianemic preparations | 2022-05 | Cancelled by sponsor | 2023-07 |
| 187648 | Daratumumab | Antineoplastic agents | 2015-11 | Issued Notice of Compliance under the NOC/c Guidance | 2016-06 |
| 255507 | Daridorexant hydrochloride | Other nervous system drugs | 2021-10 | Issued Notice of Compliance | 2023-04 |
| 226146 | Darolutamide | Endocrine therapy | 2019-04 | Issued Notice of Compliance | 2020-02 |
| 217347 | Darvadstrocel | Unassigned | 2018-08 | Cancelled by sponsor | 2019-06 |
| 284807 | Datopotamab deruxtecan | Antineoplastic agents | 2024-07 | Cancelled by sponsor | 2025-03 |
| 267589 | Davesomeran, elasomeran *For use in relation to COVID-19 | Vaccines | 2022-09 | Issued Notice of Compliance | 2022-11 |
| 207372 | Decitabine | Antineoplastic agents | 2018-03 | Issued Notice of Compliance | 2019-01 |
| 217663 | Decitabine | Antineoplastic agents | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 200808 | Defibrotide | Antithrombotic agents | 2017-01 | Issued Notice of Compliance | 2017-07 |
| 284667 | Delafloxacin meglumine | Antibacterials for systemic use | 2024-06 | Issued Notice of Compliance | 2025-01 |
| 271806 | Denosumab | Drugs for treatment of bone diseases | 2023-03 | Issued Notice of Compliance | 2024-02 |
| 267788 | Denosumab | Drugs for treatment of bone diseases | 2023-03 | Issued Notice of Compliance | 2024-03 |
| 227886 | Dequalinium chloride | Gynecological antiinfectives and antiseptics | 2019-07 | Issued Notice of Compliance | 2021-07 |
| 195186 | Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 208152 | Dermatophagoides farinae, dermatophagoides pteronyssinus | Allergens | 2017-09 | Cancelled by sponsor | 2020-07 |
| 199626 | Desvenlafaxine | Psychoanaleptics | 2017-02 | Issued Notice of Compliance | 2017-08 |
| 259397 | Deucravacitinib | Immunosuppressants | 2022-01 | Issued Notice of Compliance | 2022-11 |
| 212391 | Dexamethasone sodium phosphate, netilmicin sulfate | Ophthalmologicals | 2018-02 | Issued Notice of Compliance | 2019-10 |
| 258157 | Dexamethasone, levofloxacin | Ophthalmologicals | 2021-12 | Issued Notice of Compliance | 2023-12 |
| 254850 | Diamorphine hydrochloride | Other nervous system drugs | 2021-08 | Issued Notice of Compliance | 2022-02 |
| 254548 | Difelikefalin | All other therapeutic products | 2021-10 | Issued Notice of Compliance | 2022-08 |
| 212066 | Dinutuximab | Antineoplastic agents | 2018-02 | Issued Notice of Compliance | 2018-11 |
| 240071 | Diroximel fumarate | Immunosuppressants | 2020-07 | Cancelled by sponsor | 2023-02 |
| 220402 | Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, sodium phosphate monobasic | All other non-therapeutic products | 2018-11 | Issued Notice of Compliance | 2019-09 |
| 206402 | Dolutegravir sodium, rilpivirine hydrochloride | Antivirals for systemic use | 2017-07 | Issued Notice of Compliance | 2018-05 |
| 220275 | Dolutegravir, lamivudine | Antivirals for systemic use | 2018-10 | Issued Notice of Compliance | 2019-08 |
| 211293 | Doravirine | Antivirals for systemic use | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 211708 | Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | 2018-01 | Issued Notice of Compliance | 2018-11 |
| 251105 | Dostarlimab | Antineoplastic agents | 2021-04 | Issued Notice of Compliance under the NOC/c Guidance | 2021-12 |
| 218346 | Dotatate | Diagnostic radiopharmaceuticals | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 240372 | Dronabinol | Antiemetics and antinauseants | 2021-05 | Cancelled by sponsor | 2023-05 |
| 242176 | Drospirenone | Sex hormones and modulators of the genital system | 2021-02 | Issued Notice of Compliance | 2021-11 |
| 236197 | Drospirenone, estetrol monohydrate | Sex hormones and modulators of the genital system | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 201285 | Dupilumab | Immunosuppressants | 2017-02 | Issued Notice of Compliance | 2017-11 |
| 202953 | Durvalumab | Antineoplastic agents | 2017-03 | Issued Notice of Compliance under the NOC/c Guidance | 2017-11 |
| 208834 | Durvalumab | Antineoplastic agents | 2017-09 | Issued Notice of Compliance under the NOC/c Guidance | 2018-05 |
| 256568 | Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live, attenuated) | Vaccines | 2021-10 | Issued Notice of Compliance | 2022-11 |
| 214391 | Edaravone | Other nervous system drugs | 2018-04 | Issued Notice of Compliance | 2018-10 |
| 187363 | Edoxaban | Antithrombotic agents | 2015-12 | Issued Notice of Compliance | 2016-11 |
| 283753 | Efanesoctocog alfa | Antihemorrhagics | 2024-05 | Issued Notice of Compliance | 2025-03 |
| 267438 | Efgartigimod alfa | Immunosuppressants | 2022-11 | Issued Notice of Compliance | 2023-09 |
| 209513 | Elagolix | Sex hormones and modulators of the genital system | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 244946 | Elasomeran *For use in relation to COVID-19 | Vaccines | 2020-10 | Authorized under Interim Order | 2020-12 |
| 252733 | Elasomeran *For use in relation to COVID-19 | Vaccines | Issued Notice of Compliance | 2021-09 | |
| 265656 | Elasomeran, imelasomeran *For use in relation to COVID-19 | Vaccines | 2022-06 | Issued Notice of Compliance | 2022-09 |
| 185866 | Elbasvir, grazoprevir | Antivirals for systemic use | 2015-07 | Issued Notice of Compliance | 2016-01 |
| 246955 | Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 2020-12 | Issued Notice of Compliance | 2021-06 |
| 183050 | Eliglustat tartrate | Other alimentary tract and metabolism products | 2015-05 | Issued Notice of Compliance | 2017-04 |
| 188144 | Elotuzumab | Antineoplastic agents | 2015-12 | Issued Notice of Compliance | 2016-06 |
| 273519 | Elranatamab | Antineoplastic agents | 2023-04 | Issued Notice of Compliance under the NOC/c Guidance | 2023-12 |
| 190162 | Eluxadoline | Drugs for functional gastrointestinal disorders | 2016-04 | Issued Notice of Compliance | 2017-01 |
| 237121 | Emapalumab | Immunosuppressants | 2020-05 | Cancelled by sponsor | 2021-01 |
| 212635 | Emicizumab | Antihemorrhagics | 2018-02 | Issued Notice of Compliance | 2018-08 |
| 217033 | Enasidenib mesylate | Antineoplastic agents | 2018-07 | Issued Notice of Compliance under the NOC/c Guidance | 2019-02 |
| 237413 | Encorafenib | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 238571 | Encorafenib | Antineoplastic agents | 2020-06 | Issued Notice of Compliance | 2021-03 |
| 251438 | Enfortumab vedotin | Antineoplastic agents | 2021-05 | Issued Notice of Compliance | 2021-10 |
| 233058 | Enoxaparin sodium | Antithrombotic agents | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 233987 | Enoxaparin sodium | Antithrombotic agents | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 231767 | Enoxaparin sodium | Antithrombotic agents | 2019-11 | Issued Notice of Compliance | 2020-12 |
| 243026 | Enoxaparin sodium | Antithrombotic agents | 2021-12 | Issued Notice of Compliance | 2022-10 |
| 266545 | Enoxaparin sodium | Antithrombotic agents | 2022-09 | Issued Notice of Compliance | 2023-07 |
| 262815 | Enterococcus faecalis inactivated, Escherichia coli inactivated, Klebsiella pneumoniae inactivated, Proteus vulgaris inactivated | Vaccines | 2022-05 | Cancelled by sponsor | 2023-05 |
| 227517 | Entrectinib | Antineoplastic agents | 2019-06 | Issued Notice of Compliance under the NOC/c Guidance | 2020-02 |
| 228159 | Entrectinib | Antineoplastic agents | 2019-07 | Issued Notice of Compliance | 2020-05 |
| 271331 | Epcoritamab | Antineoplastic agents | 2023-02 | Issued Notice of Compliance under the NOC/c Guidance | 2023-10 |
| 274598 | Eplontersen | Other nervous system drugs | 2023-08 | Issued Notice of Compliance | 2024-06 |
| 233288 | Eptinezumab | Analgesics | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 224529 | Erdafitinib | Antineoplastic agents | 2019-03 | Issued Notice of Compliance under the NOC/c Guidance | 2019-10 |
| 208607 | Erenumab | Analgesics | 2017-10 | Issued Notice of Compliance | 2018-08 |
| 204724 | Ertugliflozin pidolate | Drugs used in diabetes | 2017-07 | Issued Notice of Compliance | 2018-05 |
| 201005 | Ertugliflozin pidolate, metformin hydrochloride | Drugs used in diabetes | 2017-08 | Issued Notice of Compliance | 2018-05 |
| 201006 | Ertugliflozin pidolate, sitagliptin phosphate monohydrate | Drugs used in diabetes | 2017-07 | Issued Notice of Compliance | 2018-05 |
| 255132 | Erwinia L-asparaginase | Antineoplastic agents | 2021-09 | Cancelled by sponsor | 2023-07 |
| 222855 | Esketamine hydrochloride | Psychoanaleptics | 2019-01 | Issued Notice of Compliance | 2020-05 |
| 223938 | Estradiol hemihydrate | Sex hormones and modulators of the genital system | 2019-10 | Issued Notice of Compliance | 2020-08 |
| 224010 | Estradiol hemihydrate, progesterone | Sex hormones and modulators of the genital system | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 267148 | Estradiol, norethindrone acetate, relugolix | Pituitary and hypothalamic hormones and analogues | 2022-11 | Issued Notice of Compliance | 2023-09 |
| 268111 | Estradiol, norethindrone acetate, relugolix | Pituitary and hypothalamic hormones and analogues | 2022-12 | Issued Notice of Compliance | 2023-10 |
| 203472 | Estriol, lactobacillus acidophilus | Sex hormones and modulators of the genital system | 2017-06 | Issued Notice of Deficiency - Withdrawal | 2019-01 |
| 193864 | Etanercept | Immunosuppressants | 2016-06 | Issued Notice of Compliance | 2017-04 |
| 234562 | Etanercept | Immunosuppressants | 2020-02 | Issued Notice of Compliance | 2022-08 |
| 256653 | Etesevimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-09 | Cancelled by sponsor | 2023-02 |
| 279315 | Ethinyl estradiol, segesterone acetate | Sex hormones and modulators of the genital system | 2023-11 | Issued Notice of Compliance | 2024-12 |
| 231245 | Etomidate | Anesthetics | 2019-12 | Issued Notice of Compliance | 2020-07 |
| 226314 | Etonogestrel | Sex hormones and modulators of the genital system | 2019-05 | Issued Notice of Compliance | 2020-05 |
| 273721 | Etranacogene dezaparvovec | Other hematological agents | 2023-04 | Issued Notice of Compliance | 2023-10 |
| 271038 | Etrasimod L-arginine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2023-03 | Issued Notice of Compliance | 2024-01 |
| 272688 | Evinacumab | Lipid modifying agents | 2023-03 | Issued Notice of Compliance | 2023-09 |
| 284351 | Exagamglogene autotemcel | Other hematological agents | 2024-03 | Issued Notice of Compliance | 2024-09 |
| 267502 | Famtozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | 2022-09 | Issued Notice of Compliance | 2022-10 |
| 253904 | Faricimab | Ophthalmologicals | 2021-08 | Issued Notice of Compliance | 2022-05 |
| 256417 | Favipiravir *For use in relation to COVID-19 | Antivirals for systemic use | 2021-09 | Cancelled by sponsor | 2022-02 |
| 285129 | Fecal microbiota | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2024-05 | Issued Notice of Compliance | 2025-03 |
| 229866 | Fedratinib dihydrochloride monohydrate | Antineoplastic agents | 2019-10 | Issued Notice of Compliance | 2020-07 |
| 272960 | Ferric carboxymaltose | Antianemic preparations | 2023-04 | Issued Notice of Compliance | 2024-03 |
| 260666 | Ferric maltol | Antianemic preparations | 2022-06 | Issued Notice of Compliance | 2024-08 |
| 239850 | Ferric pyrophosphate citrate | Antianemic preparations | 2020-06 | Issued Notice of Compliance | 2021-04 |
| 258248 | Ferumoxytol | Antianemic preparations | 2022-03 | Cancelled by sponsor | 2023-02 |
| 280470 | Fezolinetant | Other gynecologicals | 2024-01 | Issued Notice of Compliance | 2024-12 |
| 195870 | Fibrinogen (human) | Antihemorrhagics | 2016-08 | Issued Notice of Compliance | 2017-06 |
| 239016 | Fibrinogen (human), thrombin (human) | Antihemorrhagics | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 275853 | Fidanacogene elaparvovec | Antihemorrhagics | 2023-06 | Issued Notice of Compliance | 2023-12 |
| 235219 | Filgotinib | Immunosuppressants | 2020-04 | Cancelled by sponsor | 2021-01 |
| 212016 | Filgrastim (r-metHuG-CSF) | Immunostimulants | 2018-02 | Cancelled by sponsor | 2019-08 |
| 214080 | Filgrastim (r-metHuG-CSF) | Immunostimulants | 2018-04 | Issued Notice of Compliance | 2020-04 |
| 220512 | Filgrastim (r-metHuG-CSF) | Immunostimulants | 2019-03 | Issued Notice of Compliance | 2021-10 |
| 267597 | Filgrastim (r-metHuG-CSF) | Immunostimulants | 2023-01 | Cancelled by sponsor | 2024-07 |
| 273870 | Filgrastim (r-metHuG-CSF) | Immunostimulants | 2024-05 | Issued Notice of Compliance | 2025-03 |
| 249486 | Finerenone | Diuretics | 2021-04 | Cancelled by sponsor | 2021-10 |
| 258231 | Finerenone | Diuretics | 2021-12 | Issued Notice of Compliance | 2022-10 |
| 189352 | Flibanserin | Other gynecologicals | 2016-04 | Issued Notice of Compliance | 2018-02 |
| 193105 | Florbetaben (18F) | Diagnostic radiopharmaceuticals | 2016-04 | Issued Notice of Compliance | 2017-02 |
| 201510 | Fluocinolone acetonide | Ophthalmologicals | 2017-02 | Issued Notice of Compliance | 2018-11 |
| 211768 | Fluorouracil | Antineoplastic agents | 2018-04 | Issued Notice of Compliance | 2019-02 |
| 198520 | Fluoxetine hydrochloride | Psychoanaleptics | 2016-12 | Issued Notice of Compliance | 2017-06 |
| 204880 | Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 197873 | Fluticasone propionate | Drugs for obstructive airway diseases | 2016-10 | Issued Notice of Compliance | 2017-08 |
| 197974 | Fluticasone propionate, salmeterol xinafoate | Drugs for obstructive airway diseases | 2016-11 | Issued Notice of Compliance | 2018-04 |
| 188743 | Follitropin delta | Sex hormones and modulators of the genital system | 2016-01 | Issued Notice of Compliance | 2018-03 |
| 201306 | Formoterol fumarate dihydrate, glycopyrronium bromide | Drugs for obstructive airway diseases | 2017-02 | Issued Notice of Compliance | 2018-03 |
| 263826 | Foscarbidopa, foslevodopa | Anti-parkinson drugs | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 233046 | Foscarnet sodium | Antivirals for systemic use | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 219662 | Fosfomycin sodium | Antibacterials for systemic use | 2018-11 | Issued Notice of Compliance | 2019-05 |
| 232078 | Fostamatinib disodium | Antihemorrhagics | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 250213 | Fostemsavir tromethamine | Antivirals for systemic use | 2021-04 | Issued Notice of Compliance | 2021-10 |
| 226828 | Fremanezumab | Analgesics | 2019-06 | Issued Notice of Compliance | 2020-04 |
| 275803 | Fruquintinib | Antineoplastic agents | 2023-11 | Issued Notice of Compliance | 2024-09 |
| 186333 | Gadoteric acid | Contrast media | 2015-12 | Issued Notice of Compliance | 2016-11 |
| 219521 | Galcanezumab | Analgesics | 2018-10 | Issued Notice of Compliance | 2019-07 |
| 221824 | Gallium (68Ga) chloride | Diagnostic radiopharmaceuticals | 2019-04 | Issued Notice of Compliance | 2019-11 |
| 227804 | Gallium (68Ga) chloride, germanium (68Ge) chloride | Diagnostic radiopharmaceuticals | 2019-10 | Issued Notice of Compliance | 2020-08 |
| 242332 | Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | 2021-02 | Issued Notice of Compliance | 2022-10 |
| 263638 | Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | 2022-06 | Issued Notice of Compliance | 2023-04 |
| 248874 | Gallium oxodotreotide | Diagnostic radiopharmaceuticals | 2021-05 | Issued Notice of Compliance | 2022-02 |
| 221456 | Ganciclovir | Ophthalmologicals | 2019-02 | Issued Notice of Compliance | 2022-09 |
| 255697 | Gefapixant | Cough and cold preparations | 2021-12 | Cancelled by sponsor | 2024-06 |
| 223091 | Gemtuzumab ozogamicin | Antineoplastic agents | 2019-02 | Issued Notice of Compliance | 2019-11 |
| 227918 | Gilteritinib fumarate | Antineoplastic agents | 2019-06 | Issued Notice of Compliance | 2019-12 |
| 237194 | Givosiran | Bile and liver therapy | 2020-04 | Issued Notice of Compliance | 2020-10 |
| 225793 | Glasdegib | Antineoplastic agents | 2019-07 | Issued Notice of Compliance | 2020-04 |
| 202233 | Glecaprevir, pibrentasvir | Antivirals for systemic use | 2017-02 | Issued Notice of Compliance | 2017-08 |
| 265517 | Glofitamab | Antineoplastic agents | 2022-07 | Issued Notice of Compliance under the NOC/c Guidance | 2023-03 |
| 220839 | Glucagon | Pancreatic hormones | 2018-11 | Issued Notice of Compliance | 2019-09 |
| 231585 | Glycine, histidine, L-alanine, L-arginine, L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine, serine, taurine | Blood substitutes and perfusion solutions | 2020-03 | Issued Notice of Compliance | 2020-12 |
| 197038 | Glycopyrrolate | Drugs for functional gastrointestinal disorders | 2017-01 | Issued Notice of Compliance | 2017-10 |
| 228353 | Glycopyrronium bromide, indacaterol acetate, mometasone furoate | Drugs for obstructive airway diseases | 2019-09 | Issued Notice of Compliance | 2020-07 |
| 232286 | Goserelin acetate | Endocrine therapy | 2020-07 | Cancelled by sponsor | 2021-10 |
| 200590 | Guselkumab | Immunosuppressants | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 235556 | Haemagglutinin, neuraminidase antigen | Vaccines | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 289304 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain A(Yam) | Vaccines | 2024-09 | Issued Notice of Compliance | 2024-12 |
| 200726 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | 2017-05 | Issued Notice of Compliance | 2019-03 |
| 203436 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2017-04 | Issued Notice of Compliance | 2018-02 |
| 222669 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2019-01 | Issued Notice of Compliance | 2019-11 |
| 234113 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2020-01 | Cancelled by sponsor | 2020-11 |
| 212718 | Halobetasol propionate, tazarotene | Corticosteroids, dermatological preparations | 2018-05 | Issued Notice of Compliance | 2020-06 |
| 212276 | Hemin | Other alimentary tract and metabolism products | 2018-01 | Issued Notice of Compliance | 2018-07 |
| 259302 | Hepatitis B surface antigen (recombinant) | Vaccines | 2022-02 | Issued Notice of Compliance | 2022-12 |
| 205160 | Human heterologous liver cells | Other alimentary tract and metabolism products | 2017-06 | Cancelled by sponsor | 2018-07 |
| 251360 | Human insulin (recombinant) | Drugs used in diabetes | 2021-05 | Issued Notice of Compliance | 2022-08 |
| 247727 | Hyaluronidase (human recombinant), immunoglobulin (human) | Immune sera and immunoglobulins | 2021-02 | Issued Notice of Compliance | 2022-01 |
| 212396 | Hydrochlorothiazide, zofenopril calcium | Agents acting on the renin-angiotensin system | 2018-06 | Cancelled by sponsor | 2019-06 |
| 216854 | Hydrogen peroxide | Other dermatological preparations | 2018-12 | Cancelled by sponsor | 2019-08 |
| 227235 | Icosapent ethyl | Lipid modifying agents | 2019-07 | Issued Notice of Compliance | 2019-12 |
| 182503 | Idarucizumab | All other therapeutic products | 2015-05 | Issued Notice of Compliance under the NOC/c Guidance | 2016-04 |
| 244266 | Idecabtagene vicleucel | Antineoplastic agents | 2020-10 | Issued Notice of Compliance under the NOC/c Guidance | 2021-05 |
| 194291 | Immunoglobulin (human) | Immune sera and immunoglobulins | 2016-10 | Issued Notice of Compliance | 2017-08 |
| 226576 | Immunoglobulin (human) | Immune sera and immunoglobulins | 2019-06 | Issued Notice of Compliance | 2019-12 |
| 202924 | Immunoglobulin g (human) | Immune sera and immunoglobulins | 2017-04 | Issued Notice of Compliance | 2018-02 |
| 288071 | Inavolisib | Antineoplastic agents | 2024-08 | Issued Notice of Compliance | 2025-02 |
| 243470 | Inclisiran sodium | Lipid modifying agents | 2020-09 | Issued Notice of Compliance | 2021-07 |
| 227987 | Indacaterol acetate, mometasone furoate | Drugs for obstructive airway diseases | 2019-07 | Issued Notice of Compliance | 2020-05 |
| 271065 | Inebilizumab | Immunosuppressants | 2023-02 | Issued Notice of Compliance | 2023-12 |
| 246904 | Infigratinib phosphate | Antineoplastic agents | 2021-01 | Issued Notice of Compliance under the NOC/c Guidance | 2021-09 |
| 226189 | Infliximab | Immunosuppressants | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 248134 | Infliximab | Immunosuppressants | 2021-02 | Issued Notice of Compliance | 2021-12 |
| 267444 | Influenza virus type A (H1N1) | Vaccines | 2022-10 | Issued Notice of Compliance | 2023-10 |
| 214274 | Inotersen sodium | Other nervous system drugs | 2018-04 | Issued Notice of Compliance | 2018-10 |
| 204077 | Inotuzumab ozogamicin | Antineoplastic agents | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 226573 | Insulin aspart | Drugs used in diabetes | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 243229 | Insulin aspart | Drugs used in diabetes | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 198124 | Insulin degludec | Drugs used in diabetes | 2016-10 | Issued Notice of Compliance | 2017-08 |
| 194513 | Insulin degludec, liraglutide | Drugs used in diabetes | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 202772 | Insulin glargine | Drugs used in diabetes | 2017-04 | Cancelled by sponsor | 2019-02 |
| 252068 | Insulin glargine | Drugs used in diabetes | 2021-06 | Issued Notice of Compliance | 2022-04 |
| 207006 | Insulin glargine, lixisenatide | Drugs used in diabetes | 2017-09 | Issued Notice of Compliance | 2018-07 |
| 273850 | Insulin icodec | Drugs used in diabetes | 2023-05 | Issued Notice of Compliance | 2024-03 |
| 189076 | Insulin injection human biosynthetic | Drugs used in diabetes | 2016-09 | Issued Notice of Compliance | 2017-07 |
| 200792 | Insulin lispro | Drugs used in diabetes | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 244611 | Insulin lispro | Drugs used in diabetes | 2020-11 | Issued Notice of Compliance | 2021-09 |
| 196107 | Iodine | Contrast media | 2016-09 | Issued Notice of Compliance | 2017-07 |
| 201481 | Ioflupane (123I) | Diagnostic radiopharmaceuticals | 2017-02 | Issued Notice of Compliance | 2017-12 |
| 283206 | Iptacopan hydrochloride | Immunosuppressants | 2024-03 | Issued Notice of Compliance | 2025-01 |
| 189897 | Iron dextran | Antianemic preparations | 2016-05 | Cancelled by sponsor | 2017-06 |
| 193890 | Iron isomaltoside 1000 | Antianemic preparations | 2016-07 | Issued Notice of Compliance | 2018-06 |
| 229245 | Isatuximab | Antineoplastic agents | 2019-07 | Issued Notice of Compliance | 2020-04 |
| 208919 | Isavuconazonium sulfate | Antimycotics for systemic use | 2018-02 | Issued Notice of Compliance | 2018-12 |
| 263460 | Isotretinoin | Anti-acne preparations | 2022-08 | Issued Notice of Compliance | 2023-06 |
| 211292 | Ivacaftor, tezacaftor | Other respiratory system products | 2017-12 | Issued Notice of Compliance | 2018-06 |
| 211000 | Ivermectin | Anthelmintics | 2017-12 | Issued Notice of Compliance | 2018-09 |
| 277139 | Ivosidenib | Antineoplastic agents | 2023-09 | Issued Notice of Compliance | 2024-07 |
| 190498 | Ixazomib citrate | Antineoplastic agents | 2016-02 | Issued Notice of Compliance | 2016-08 |
| 184993 | Ixekizumab | Immunosuppressants | 2015-07 | Issued Notice of Compliance | 2016-05 |
| 213920 | Lanadelumab | Other hematological agents | 2018-03 | Issued Notice of Compliance | 2018-09 |
| 259953 | Landiolol hydrochloride | Beta blocking agents | 2022-02 | Issued Notice of Compliance | 2023-11 |
| 219998 | Larotrectinib | Antineoplastic agents | 2018-11 | Issued Notice of Compliance under the NOC/c Guidance | 2019-07 |
| 236369 | Lasmiditan | Analgesics | 2020-04 | Cancelled by sponsor | 2021-01 |
| 211732 | Latanoprostene bunod | Ophthalmologicals | 2018-03 | Issued Notice of Compliance | 2018-12 |
| 285014 | Lazertinib mesylate monohydrate | Antineoplastic agents | 2024-04 | Issued Notice of Compliance | 2025-03 |
| 272660 | Lebrikizumab | Other dermatological preparations | 2023-05 | Issued Notice of Compliance | 2024-06 |
| 233292 | Lefamulin acetate | Antibacterials for systemic use | 2020-01 | Issued Notice of Compliance | 2020-07 |
| 231286 | Lemborexant | Psycholeptics | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 262999 | Lenacapavir sodium | Antivirals for systemic use | 2022-05 | Issued Notice of Compliance | 2022-11 |
| 250805 | Leronlimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-03 | Interim Order expired | 2021-09 |
| 204165 | Letermovir | Antivirals for systemic use | 2017-05 | Issued Notice of Compliance | 2017-11 |
| 251157 | LetibotulinumtoxinA | Muscle relaxants | 2021-08 | Issued Notice of Compliance | 2022-06 |
| 246800 | Leuprolide mesylate | Endocrine therapy | 2021-01 | Issued Notice of Compliance | 2021-11 |
| 213656 | Levetiracetam | Antiepileptics | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 232047 | Levothyroxine sodium | Thyroid therapy | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 265823 | Lidocaine hydrochloride, nifedipine | Vasoprotectives | 2022-11 | Issued Notice of Compliance | 2024-05 |
| 199810 | Lifitegrast | Ophthalmologicals | 2016-12 | Issued Notice of Compliance | 2017-12 |
| 247562 | Lisocabtagene maraleucel | Antineoplastic agents | 2021-02 | Issued Notice of Compliance | 2022-05 |
| 193862 | Lixisenatide | Drugs used in diabetes | 2016-06 | Issued Notice of Compliance | 2017-05 |
| 284436 | Loncastuximab tesirine | Antineoplastic agents | 2024-06 | Issued Notice of Compliance under the NOC/c Guidance | 2025-03 |
| 190891 | Lonoctocog alfa | Antihemorrhagics | 2016-02 | Issued Notice of Compliance | 2016-12 |
| 198689 | Lorcaserin hydrochloride | Antiobesity preparations, excluding diet products | 2016-11 | Cancelled by sponsor | 2018-02 |
| 215733 | Lorlatinib | Antineoplastic agents | 2018-06 | Issued Notice of Compliance under the NOC/c Guidance | 2019-02 |
| 254883 | Lumasiran | Other alimentary tract and metabolism products | 2021-08 | Issued Notice of Compliance | 2022-03 |
| 247485 | Lurbinectedin | Antineoplastic agents | 2021-01 | Issued Notice of Compliance under the NOC/c Guidance | 2021-09 |
| 236441 | Luspatercept | Antianemic preparations | 2020-03 | Issued Notice of Compliance | 2020-09 |
| 236625 | Luspatercept | Antianemic preparations | 2020-04 | Issued Notice of Compliance | 2021-02 |
| 217184 | Lutetium (177Lu) oxodotretotide | Therapeutic radiopharmaceuticals | 2018-07 | Issued Notice of Compliance | 2019-01 |
| 260951 | Lutetium (177Lu) vipivotide tetraxetan | Therapeutic radiopharmaceuticals | 2022-02 | Issued Notice of Compliance | 2022-08 |
| 245848 | Macitentan, tadalafil | Antihypertensives | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 217446 | Mannitol | Diagnostic agents | 2018-08 | Issued Notice of Compliance | 2019-06 |
| 271030 | Maralixibat chloride | Bile and liver therapy | 2023-01 | Issued Notice of Compliance | 2023-07 |
| 259676 | Maribavir | Antivirals for systemic use | 2022-03 | Issued Notice of Compliance | 2022-09 |
| 280462 | Marstacimab | Antihemorrhagics | 2023-12 | Cancelled by sponsor | 2024-10 |
| 263505 | Masitinib mesylate | Antineoplastic agents | 2022-05 | Issued Notice of Deficiency - Withdrawal | 2024-02 |
| 258772 | Mavacamten | Cardiac therapy | 2022-01 | Issued Notice of Compliance | 2022-11 |
| 235023 | Mecasermin | Pituitary and hypothalamic hormones and analogues | 2020-02 | Issued Notice of Compliance | 2020-12 |
| 233632 | Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate | Vaccines | 2020-01 | Issued Notice of Compliance | 2020-10 |
| 191347 | Mercaptamine bitartrate | Other alimentary tract and metabolism products | 2016-03 | Issued Notice of Compliance | 2017-06 |
| 266553 | Meropenem trihydrate | Antibacterials for systemic use | 2023-03 | Issued Notice of Compliance | 2024-01 |
| 280730 | Meropenem trihydrate, vaborbactam | Antibacterials for systemic use | 2024-01 | Issued Notice of Compliance | 2024-12 |
| 204605 | Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 198475 | Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2017-02 | Cancelled by sponsor | 2020-08 |
| 194646 | Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2016-09 | Issued Notice of Compliance | 2021-05 |
| 247241 | Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2021-03 | Issued Notice of Compliance | 2022-01 |
| 263913 | Metformin hydrochloride | Drugs used in diabetes | 2022-07 | Issued Notice of Compliance | 2023-01 |
| 262108 | Methotrexate | Immunosuppressants | 2022-05 | Issued Notice of Compliance | 2024-03 |
| 254599 | Methotrexate sodium | Immunosuppressants | 2021-11 | Issued Notice of Compliance | 2022-09 |
| 204879 | Methoxyflurane | Analgesics | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 219788 | Methylene blue | Diagnostic agents | 2018-10 | Issued Notice of Non-compliance - Withdrawal | 2021-05 |
| 243224 | Methylphenidate hydrochloride | Psychoanaleptics | 2021-01 | Issued Notice of Compliance | 2023-09 |
| 281510 | Methylphenidate hydrochloride | Psychoanaleptics | 2024-01 | Issued Notice of Compliance | 2024-11 |
| 273908 | Metreleptin | Other alimentary tract and metabolism products | 2023-04 | Issued Notice of Compliance | 2024-01 |
| 201101 | Midostaurin | Antineoplastic agents | 2017-01 | Issued Notice of Compliance | 2017-07 |
| 196956 | Migalastat hydrochloride | Other alimentary tract and metabolism products | 2016-11 | Issued Notice of Compliance | 2017-09 |
| 266471 | Mirikizumab | Immunosuppressants | 2022-09 | Issued Notice of Compliance | 2023-07 |
| 251277 | Mogamulizumab | Antineoplastic agents | 2021-05 | Issued Notice of Compliance | 2022-06 |
| 255584 | Molnupiravir *For use in relation to COVID-19 | Antivirals for systemic use | 2021-08 | Cancelled by sponsor | 2023-04 |
| 281695 | Momelotinib dihydrochloride monohydrate | Antineoplastic agents | 2024-01 | Issued Notice of Compliance | 2024-11 |
| 199704 | Mometasone furoate | Corticosteroids, dermatological preparations | 2017-09 | Cancelled by sponsor | 2019-10 |
| 238027 | Mometasone furoate monohydrate, olopatadine hydrochloride | Nasal preparations | 2020-07 | Issued Notice of Compliance | 2022-09 |
| 193199 | Naloxone hydrochloride | All other therapeutic products | 2016-04 | Issued Notice of Compliance | 2016-10 |
| 211970 | Naloxone hydrochloride dihydrate | All other therapeutic products | 2018-01 | Cancelled by sponsor | 2019-06 |
| 281754 | Naloxone hydrochloride dihydrate | All other therapeutic products | 2024-04 | Issued Notice of Compliance | 2025-02 |
| 225848 | Naproxen sodium, sumatriptan succinate | Analgesics | 2019-05 | Issued Notice of Compliance | 2020-02 |
| 193689 | Necitumumab | Antineoplastic agents | 2016-05 | Issued Notice of Compliance | 2017-03 |
| 195550 | Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B | Vaccines | 2016-07 | Issued Notice of Compliance | 2017-10 |
| 218224 | Neratinib maleate | Antineoplastic agents | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 196495 | Netupitant, palonosetron hydrochloride | Antiemetics and antinauseants | 2016-12 | Issued Notice of Compliance | 2017-09 |
| 216257 | Nicardipine hydrochloride | Calcium channel blockers | 2018-07 | Issued Notice of Non-compliance - Withdrawal | 2020-04 |
| 216792 | Niraparib | Antineoplastic agents | 2018-09 | Issued Notice of Compliance | 2019-06 |
| 259186 | Nirmatrelvir, ritonavir *For use in relation to COVID-19 | Antivirals for systemic use | 2021-12 | Issued Notice of Compliance | 2022-01 |
| 269388 | Nirsevimab | Immune sera and immunoglobulins | 2022-12 | Issued Notice of Compliance | 2023-04 |
| 190564 | Nitisinone | Other alimentary tract and metabolism products | 2016-03 | Issued Notice of Compliance | 2016-09 |
| 193770 | Nitisinone | Other alimentary tract and metabolism products | 2016-05 | Issued Notice of Compliance | 2016-11 |
| 193226 | Nitisinone | Other alimentary tract and metabolism products | 2016-07 | Issued Notice of Compliance | 2016-12 |
| 253630 | Nitric oxide *For use in relation to COVID-19 | Other nervous system drugs | 2021-06 | Cancelled by sponsor | 2021-09 |
| 256629 | Nivolumab, relatlimab | Antineoplastic agents | 2022-09 | Issued Notice of Compliance | 2023-09 |
| 200070 | Nusinersen | Other drugs for disorders of the musculo-skeletal system | 2016-12 | Issued Notice of Compliance | 2017-06 |
| 198418 | Obeticholic acid | Bile and liver therapy | 2016-10 | Issued Notice of Compliance under the NOC/c Guidance | 2017-05 |
| 230825 | Obiltoxaximab | Immune sera and immunoglobulins | 2019-10 | Issued Notice of Compliance | 2020-07 |
| 198094 | Ocrelizumab | Immunosuppressants | 2016-10 | Issued Notice of Compliance | 2017-08 |
| 197969 | Ocrelizumab | Immunosuppressants | 2016-10 | Issued Notice of Compliance under the NOC/c Guidance | 2018-02 |
| 273741 | Odevixibat | Bile and liver therapy | 2023-05 | Issued Notice of Compliance | 2023-10 |
| 237346 | Ofatumumab | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-01 |
| 182823 | Olaparib | Antineoplastic agents | 2015-06 | Issued Notice of Compliance under the NOC/c Guidance | 2016-04 |
| 203478 | Olaratumab | Antineoplastic agents | 2017-04 | Issued Notice of Compliance under the NOC/c Guidance | 2017-11 |
| 275236 | Olipudase alfa | Other alimentary tract and metabolism products | 2023-06 | Issued Notice of Compliance | 2024-02 |
| 279053 | Omalizumab | Drugs for obstructive airway diseases | 2024-02 | Issued Notice of Compliance | 2024-12 |
| 289541 | Omaveloxolone | Other nervous system drugs | 2024-09 | Issued Notice of Compliance | 2025-03 |
| 239719 | Onasemnogene abeparvovec | Other drugs for disorders of the musculo-skeletal system | 2020-06 | Issued Notice of Compliance | 2020-12 |
| 188171 | Osimertinib | Antineoplastic agents | 2015-11 | Issued Notice of Compliance under the NOC/c Guidance | 2016-07 |
| 222001 | Ospemifene | Sex hormones and modulators of the genital system | 2019-03 | Issued Notice of Compliance | 2021-07 |
| 198865 | Oxycodone | Analgesics | 2016-11 | Cancelled by sponsor | 2018-07 |
| 232761 | Ozanimod hydrochloride | Immunosuppressants | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 192925 | Ozenoxacin | Antibiotics and chemotherapy for dermatological use | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 252065 | Palovarotene | Other drugs for disorders of the musculo-skeletal system | 2021-07 | Issued Notice of Compliance | 2022-01 |
| 187504 | Panobinostat | Antineoplastic agents | 2015-11 | Cancelled by sponsor | 2016-06 |
| 210368 | Patiromer sorbitex calcium | All other therapeutic products | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 221896 | Patisiran | Other nervous system drugs | 2018-12 | Issued Notice of Compliance | 2019-06 |
| 189795 | Pegaspargase | Antineoplastic agents | 2016-05 | Issued Notice of Compliance | 2017-02 |
| 263432 | Pegcetaclopan | Immunosuppressants | 2022-06 | Issued Notice of Compliance | 2022-12 |
| 272381 | Pegcetaclopan | Immunosuppressants | 2023-03 | Cancelled by sponsor | 2025-01 |
| 204841 | Pegfilgrastim | Immunostimulants | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 200807 | Pegfilgrastim | Immunostimulants | 2017-01 | Issued Notice of Compliance | 2018-12 |
| 220445 | Pegfilgrastim | Immunostimulants | 2019-05 | Issued Notice of Compliance | 2020-04 |
| 233373 | Pegfilgrastim | Immunostimulants | 2020-01 | Issued Notice of Compliance | 2020-10 |
| 232048 | Pegfilgrastim | Immunostimulants | 2019-11 | Cancelled by sponsor | 2021-07 |
| 262438 | Pegfilgrastim | Immunostimulants | 2022-05 | Issued Notice of Compliance | 2024-04 |
| 271699 | Pegfilgrastim | Immunostimulants | 2023-06 | Cancelled by sponsor | 2024-07 |
| 262990 | Pegfilgrastim | Immunostimulants | 2022-05 | Issued Notice of Compliance | 2024-08 |
| 273871 | Pegfilgrastim | Immunostimulants | 2023-12 | Issued Notice of Compliance | 2024-12 |
| 251687 | Pegvaliase | Other alimentary tract and metabolism products | 2021-06 | Issued Notice of Compliance | 2022-03 |
| 242569 | Pemigatinib | Antineoplastic agents | 2020-10 | Issued Notice of Compliance under the NOC/c Guidance | 2021-09 |
| 191280 | Peramivir | Antivirals for systemic use | 2016-03 | Issued Notice of Compliance | 2017-01 |
| 272066 | Perfluorohexyloctane | Ophthalmologicals | 2023-08 | Issued Notice of Compliance | 2024-09 |
| 201189 | Perindopril arginine | Agents acting on the renin-angiotensin system | 2017-08 | Issued Notice of Compliance | 2018-03 |
| 237402 | Pertuzumab, trastuzumab | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 238175 | Pitolisant | Other nervous system drugs | 2020-05 | Issued Notice of Compliance | 2021-05 |
| 215288 | Plecanatide | Drugs for constipation | 2018-12 | Issued Notice of Compliance | 2019-10 |
| 232303 | Polatuzumab vedotin | Antineoplastic agents | 2019-11 | Issued Notice of Compliance under the NOC/c Guidance | 2020-07 |
| 239537 | Ponesimod | Immunosuppressants | 2020-07 | Issued Notice of Compliance | 2021-04 |
| 208364 | PrabotulinumtoxinA | Muscle relaxants | 2017-10 | Issued Notice of Compliance | 2018-08 |
| 207545 | Pralatrexate | Antineoplastic agents | 2017-11 | Issued Notice of Compliance under the NOC/c Guidance | 2018-10 |
| 243731 | Pralsetinib | Antineoplastic agents | 2020-11 | Issued Notice of Compliance under the NOC/c Guidance | 2021-06 |
| 252270 | Pralsetinib | Antineoplastic agents | 2021-06 | Cancelled by sponsor | 2022-04 |
| 198822 | Prasterone | Anabolic agents for systemic use | 2016-12 | Issued Notice of Compliance | 2019-11 |
| 211548 | Progesterone | Sex hormones and modulators of the genital system | 2018-02 | Issued Notice of Compliance | 2018-08 |
| 239820 | Progesterone | Sex hormones and modulators of the genital system | 2020-07 | Issued Notice of Compliance | 2021-04 |
| 188323 | Propiverine hydrochloride | Urologicals | 2016-03 | Issued Notice of Compliance | 2017-01 |
| 211541 | Rabies immune globulin human | Immune sera and immunoglobulins | 2018-01 | Issued Notice of Compliance | 2018-11 |
| 251162 | Ranibizumab | Ophthalmologicals | 2021-05 | Issued Notice of Compliance | 2022-03 |
| 254848 | Ranibizumab | Ophthalmologicals | 2021-09 | Issued Notice of Compliance | 2022-09 |
| 268288 | Ranibizumab | Ophthalmologicals | 2022-12 | Issued Notice of Compliance | 2023-10 |
| 239943 | Ranolazine | Cardiac therapy | 2020-07 | Issued Notice of Compliance | 2020-12 |
| 217955 | Ravulizumab | Immunosuppressants | 2018-11 | Issued Notice of Compliance | 2019-08 |
| 276302 | Raxtozinameran *For use in relation to COVID-19 | Vaccines | 2023-06 | Issued Notice of Compliance | 2023-09 |
| 180793 | Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) | Antihemorrhagics | 2015-04 | Issued Notice of Compliance | 2016-01 |
| 230211 | Recombinant haemagglutinin-strain A (H1N1) virus-like particles, Recombinant haemagglutinin-strain A (H3N2) virus-like particles, Recombinant haemagglutinin-strain B (Victoria lineage) virus-like particles, Recombinant haemagglutinin-strain B (Yamagata lineage) virus-like particles | Vaccines | 2019-09 | Cancelled by sponsor | 2021-09 |
| 235672 | Recombinant influenza strain A H1N1 HA protein, recombinant influenza strain A H3N2 HA protein, recombinant influenza strain B (Victoria lineage) HA protein, recombinant influenza strain B (Yamagata lineage) HA protein | Vaccines | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 252929 | Regdanvimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-05 | Cancelled by sponsor | 2024-07 |
| 271756 | RelabotulinumtoxinA | Muscle relaxants | 2023-03 | Cancelled by sponsor | 2024-01 |
| 269372 | Relugolix | Endocrine therapy | 2022-12 | Issued Notice of Compliance | 2023-10 |
| 240551 | Remdesivir | Antivirals for systemic use | 2020-06 | Issued Notice of Compliance under the NOC/c Guidance | 2020-07 |
| 185873 | Reslizumab | Immunosuppressants | 2015-09 | Issued Notice of Compliance | 2016-07 |
| 269021 | Respiratory syncytial virus prefusion F protein (RSVPreF3) | Vaccines | 2022-11 | Issued Notice of Compliance | 2023-08 |
| 284125 | Retifanlimab | Antineoplastic agents | 2024-04 | Issued Notice of Compliance | 2025-02 |
| 203884 | Ribociclib | Antineoplastic agents | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 266189 | Riltozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | 2022-07 | Issued Notice of Compliance | 2022-10 |
| 268384 | Rimegepant | Analgesics | 2023-01 | Issued Notice of Compliance | 2023-12 |
| 234688 | Ripretinib | Antineoplastic agents | 2020-03 | Issued Notice of Compliance | 2020-06 |
| 215753 | Risankizumab | Immunosuppressants | 2018-06 | Issued Notice of Compliance | 2019-04 |
| 242373 | Risdiplam | Other drugs for disorders of the musculo-skeletal system | 2020-10 | Issued Notice of Compliance | 2021-04 |
| 233331 | Risperidone | Psycholeptics | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 264840 | Risperidone | Psycholeptics | 2022-12 | Issued Notice of Compliance | 2024-03 |
| 268723 | Ritlecitinib | Immunosuppressants | 2023-02 | Issued Notice of Compliance | 2023-11 |
| 207702 | Rituximab | Antineoplastic agents | 2017-09 | Cancelled by sponsor | 2019-03 |
| 208107 | Rituximab | Antineoplastic agents | 2017-09 | Cancelled by sponsor | 2019-03 |
| 208204 | Rituximab | Antineoplastic agents | 2017-09 | Issued Notice of Compliance | 2019-04 |
| 224672 | Rituximab | Antineoplastic agents | 2019-03 | Cancelled by sponsor | 2019-04 |
| 214058 | Rituximab | Antineoplastic agents | 2018-04 | Issued Notice of Compliance | 2020-04 |
| 224164 | Rituximab | Antineoplastic agents | 2019-03 | Issued Notice of Compliance | 2020-05 |
| 237814 | Rituximab | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 264296 | Roflumilast | Other dermatological preparations | 2022-07 | Issued Notice of Compliance | 2023-04 |
| 197713 | Romosozumab | Drugs for treatment of bone diseases | 2016-10 | Issued Notice of Compliance | 2019-06 |
| 271972 | Ropivacaine hydrochloride | Anesthetics | 2023-05 | Issued Notice of Compliance | 2025-03 |
| 236566 | Roxadustat | Antianemic preparations | 2020-03 | Cancelled by sponsor | 2021-10 |
| 274979 | Rozanolixizumab | Other drugs for disorders of the musculo-skeletal system | 2023-11 | Issued Notice of Compliance | 2025-03 |
| 279310 | RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) | Vaccines | 2024-01 | Issued Notice of Compliance | 2024-11 |
| 272785 | RSV subgroups A, B stabilized prefusion F protein | Vaccines | 2023-03 | Issued Notice of Compliance | 2023-12 |
| 186488 | Rupatadine fumarate | Antihistamines for systemic use | 2015-09 | Issued Notice of Compliance | 2016-07 |
| 269729 | Ruxolitinib phosphate | Other dermatological preparations | 2023-03 | Issued Notice of Compliance | 2024-10 |
| 270055 | Sabizabulin *For use in relation to COVID-19 | Antivirals for systemic use | 2022-11 | Cancelled by sponsor | 2023-06 |
| 248753 | Sacituzumab govitecan | Antineoplastic agents | 2021-03 | Issued Notice of Compliance | 2021-09 |
| 207115 | Safinamide | Anti-parkinson drugs | 2018-03 | Issued Notice of Compliance | 2019-01 |
| 189577 | Salbutamol sulfate | Drugs for obstructive airway diseases | 2016-11 | Issued Notice of Compliance | 2017-11 |
| 191745 | Sarilumab | Immunosuppressants | 2016-03 | Issued Notice of Compliance | 2017-01 |
| 254715 | SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 | Vaccines | 2021-07 | Cancelled by sponsor | 2023-02 |
| 269939 | SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 | Vaccines | 2022-12 | Cancelled by sponsor | 2023-02 |
| 278519 | SARS-CoV-2 recombinant spike protein (Omicron XBB.1.5) *For use in relation to COVID-19 | Vaccines | 2023-09 | Issued Notice of Compliance | 2023-12 |
| 255370 | SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 | Vaccines | 2021-08 | Issued Notice of Compliance | 2022-02 |
| 233642 | Satralizumab | Immunosuppressants | 2019-12 | Issued Notice of Compliance | 2020-06 |
| 204085 | Sebelipase alfa | Other alimentary tract and metabolism products | 2017-04 | Issued Notice of Compliance under the NOC/c Guidance | 2017-12 |
| 253182 | Selinexor | Antineoplastic agents | 2021-08 | Issued Notice of Compliance | 2022-05 |
| 243748 | Selpercatinib | Antineoplastic agents | 2020-10 | Issued Notice of Compliance under the NOC/c Guidance | 2021-06 |
| 243733 | Selumetinib | Antineoplastic agents | 2020-11 | Issued Notice of Compliance | 2022-08 |
| 202059 | Semaglutide | Drugs used in diabetes | 2017-03 | Issued Notice of Compliance | 2018-01 |
| 226906 | Semaglutide | Drugs used in diabetes | 2019-06 | Issued Notice of Compliance | 2020-03 |
| 247235 | Semaglutide | Drugs used in diabetes | 2021-01 | Issued Notice of Compliance | 2021-11 |
| 268412 | Setmelanotide acetate | Antiobesity preparations, excluding diet products | 2022-11 | Issued Notice of Compliance | 2023-05 |
| 283047 | Sipavibart | Immune sera and immunoglobulins | 2024-03 | Issued Notice of Compliance | 2025-03 |
| 223225 | Siponimod | Immunosuppressants | 2019-02 | Issued Notice of Compliance | 2020-02 |
| 205568 | Sirukumab | Immunosuppressants | 2017-06 | Cancelled by sponsor | 2017-10 |
| 270800 | Smallpox vaccine dried | Vaccines | 2023-02 | Issued Notice of Compliance | 2023-12 |
| 225953 | Sodium chloride, sodium citrate | Blood substitutes and perfusion solutions | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 231915 | Sodium pertechnetate Tc-99m | Diagnostic radiopharmaceuticals | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 253502 | Sodium phenylbutyrate, ursodoxicoltaurine | Other nervous system drugs | 2021-08 | Issued Notice of Compliance under the NOC/c Guidance | 2022-06 |
| 218799 | Sodium zirconium cyclosilicate | All other therapeutic products | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 190521 | Sofosbuvir, velpatasvir | Antivirals for systemic use | 2016-01 | Issued Notice of Compliance | 2016-07 |
| 202324 | Sofosbuvir, velpatasvir, voxilaprevir | Antivirals for systemic use | 2017-02 | Issued Notice of Compliance | 2017-08 |
| 237511 | Solriamfetol hydrochloride | Psychoanaleptics | 2020-07 | Issued Notice of Compliance | 2021-05 |
| 267443 | Somapacitan | Pituitary and hypothalamic hormones and analogues | 2022-09 | Issued Notice of Compliance | 2023-07 |
| 246729 | Somatrogon | Pituitary and hypothalamic hormones and analogues | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 229407 | Sonidegib | Antineoplastic agents | 2019-08 | Issued Notice of Compliance | 2020-06 |
| 217853 | Sotagliflozin | Drugs used in diabetes | 2018-08 | Cancelled by sponsor | 2019-06 |
| 283307 | Sotatercept | Antihypertensives | 2024-03 | Issued Notice of Compliance | 2024-08 |
| 248435 | Sotorasib | Antineoplastic agents | 2021-02 | Issued Notice of Compliance under the NOC/c Guidance | 2021-09 |
| 251285 | Sotrovimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-04 | Authorized under Interim Order | 2021-07 |
| 257895 | Sotrovimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2021-10 | Cancelled by sponsor | 2024-04 |
| 267362 | Spesolimab | Immunosuppressants | 2022-09 | Issued Notice of Compliance | 2023-03 |
| 201492 | Sucroferric oxyhydroxide | All other therapeutic products | 2017-02 | Issued Notice of Compliance | 2018-01 |
| 180385 | Sugammadex | All other therapeutic products | 2015-04 | Issued Notice of Compliance | 2016-02 |
| 196367 | Suvorexant | Psycholeptics | 2016-08 | Issued Notice of Compliance | 2018-11 |
| 209210 | Tacrolimus | Immunosuppressants | 2018-04 | Issued Notice of Compliance | 2019-02 |
| 240239 | Tafamidis | Other nervous system drugs | 2020-09 | Issued Notice of Compliance | 2021-07 |
| 228368 | Tafamidis meglumine | Other nervous system drugs | 2019-07 | Issued Notice of Compliance | 2020-01 |
| 247025 | Tafasitamab | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-08 |
| 220584 | Talazoparib | Antineoplastic agents | 2018-11 | Issued Notice of Compliance | 2019-09 |
| 278277 | Talquetamab | Antineoplastic agents | 2023-09 | Issued Notice of Compliance under the NOC/c Guidance | 2024-04 |
| 281963 | Tarlatamab | Antineoplastic agents | 2024-01 | Issued Notice of Compliance under the NOC/c Guidance | 2024-09 |
| 236286 | Tazarotene | Antipsoriatics | 2020-09 | Issued Notice of Compliance | 2021-07 |
| 258717 | Tebentafusp | Antineoplastic agents | 2021-12 | Issued Notice of Compliance | 2022-06 |
| 269369 | Teclistamab | Antineoplastic agents | 2022-12 | Issued Notice of Compliance under the NOC/c Guidance | 2023-07 |
| 247561 | Tecovirimat monohydrate | Antivirals for systemic use | 2021-02 | Issued Notice of Compliance | 2021-11 |
| 208730 | Telotristat etiprate | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 224850 | Tenapanor | Drugs for constipation | 2019-06 | Issued Notice of Compliance | 2020-04 |
| 193066 | Tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 242300 | Tepotinib | Antineoplastic agents | 2020-10 | Issued Notice of Compliance under the NOC/c Guidance | 2021-05 |
| 215409 | Teriparatide | Calcium homeostasis | 2018-06 | Issued Notice of Compliance | 2020-01 |
| 256188 | Tezepelumab | Drugs for obstructive airway diseases | 2021-10 | Issued Notice of Compliance | 2022-07 |
| 206099 | Tibolone | Sex hormones and modulators of the genital system | 2017-10 | Issued Notice of Compliance | 2019-05 |
| 224036 | Tildrakizumab | Immunosuppressants | 2019-02 | Issued Notice of Compliance | 2021-05 |
| 205852 | Tipiracil hydrochloride, trifluridine | Antineoplastic agents | 2017-07 | Issued Notice of Compliance | 2018-01 |
| 262080 | Tirbanibulin | Antibiotics and chemotherapy for dermatological use | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 259103 | Tirzepatide | Drugs used in diabetes | 2022-02 | Issued Notice of Compliance | 2022-11 |
| 213547 | Tisagenlecleucel-T | Antineoplastic agents | 2018-03 | Issued Notice of Compliance | 2018-09 |
| 213698 | Tisagenlecleucel-T | Antineoplastic agents | 2018-03 | Issued Notice of Compliance | 2018-09 |
| 280011 | Tocilizumab | Immunosuppressants | 2023-12 | Issued Notice of Compliance | 2024-10 |
| 283158 | Tofersen | Other nervous system drugs | 2024-03 | Issued Notice of Compliance under the NOC/c Guidance | 2025-02 |
| 244906 | Tozinameran *For use in relation to COVID-19 | Vaccines | 2020-10 | Authorized under Interim Order | 2020-12 |
| 252736 | Tozinameran *For use in relation to COVID-19 | Vaccines | Issued Notice of Compliance | 2021-09 | |
| 245877 | Tralokinumab | Other dermatological preparations | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 204579 | Trastuzumab | Antineoplastic agents | 2017-06 | Issued Notice of Compliance | 2019-05 |
| 212140 | Trastuzumab | Antineoplastic agents | 2018-02 | Issued Notice of Compliance | 2019-08 |
| 210238 | Trastuzumab | Antineoplastic agents | 2017-11 | Issued Notice of Compliance | 2019-09 |
| 208836 | Trastuzumab | Antineoplastic agents | 2017-10 | Issued Notice of Compliance | 2020-02 |
| 235995 | Trastuzumab | Antineoplastic agents | 2020-04 | Issued Notice of Compliance | 2022-01 |
| 253850 | Trastuzumab | Antineoplastic agents | 2021-08 | Cancelled by sponsor | 2023-06 |
| 275910 | Trastuzumab | Antineoplastic agents | 2023-07 | Issued Notice of Compliance | 2024-08 |
| 242104 | Trastuzumab deruxtecan | Antineoplastic agents | 2020-08 | Issued Notice of Compliance under the NOC/c Guidance | 2021-04 |
| 262740 | Tremelimumab | Antineoplastic agents | 2022-05 | Issued Notice of Compliance | 2023-08 |
| 231223 | Treosulfan | Antineoplastic agents | 2020-01 | Issued Notice of Deficiency - Withdrawal | 2021-06 |
| 244137 | Treosulfan | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-06 |
| 201546 | Triamcinolone hexacetonide | Corticosteroids for systemic use | 2017-02 | Issued Notice of Compliance | 2017-12 |
| 228708 | Trientine hydrochloride | Other alimentary tract and metabolism products | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 237287 | Trientine hydrochloride | All other therapeutic products | 2020-06 | Issued Notice of Compliance | 2021-04 |
| 221945 | Trifarotene | Anti-acne preparations | 2019-01 | Issued Notice of Compliance | 2019-11 |
| 242196 | Triheptanoin | Other alimentary tract and metabolism products | 2020-08 | Issued Notice of Compliance | 2021-02 |
| 285051 | Trofinetide | Other nervous system drugs | 2024-04 | Issued Notice of Compliance | 2024-10 |
| 235295 | Tucatinib | Antineoplastic agents | 2020-02 | Issued Notice of Compliance | 2020-06 |
| 256191 | Ubrogepant | Analgesics | 2021-10 | Issued Notice of Compliance | 2022-11 |
| 223734 | Upadacitinib | Immunosuppressants | 2019-03 | Issued Notice of Compliance | 2019-12 |
| 268742 | Ustekinumab | Immunosuppressants | 2023-01 | Issued Notice of Compliance | 2023-11 |
| 269097 | Ustekinumab | Immunosuppressants | 2023-03 | Issued Notice of Compliance | 2023-12 |
| 274939 | Ustekinumab | Immunosuppressants | 2023-08 | Issued Notice of Compliance | 2024-07 |
| 277532 | Ustekinumab | Immunosuppressants | 2023-10 | Issued Notice of Compliance | 2024-08 |
| 278712 | Ustekinumab | Immunosuppressants | 2023-10 | Issued Notice of Compliance | 2024-08 |
| 279373 | Ustekinumab | Immunosuppressants | 2024-03 | Issued Notice of Compliance | 2024-12 |
| 200244 | Varicella-zoster virus glycoprotein E (GE) | Vaccines | 2016-12 | Issued Notice of Compliance | 2017-10 |
| 190761 | Venetoclax | Antineoplastic agents | 2016-02 | Issued Notice of Compliance under the NOC/c Guidance | 2016-09 |
| 240862 | Vericiguat | Cardiac therapy | 2021-01 | Issued Notice of Compliance | 2023-04 |
| 190817 | Vernakalant hydrochloride | Cardiac therapy | 2016-05 | Issued Notice of Compliance | 2017-03 |
| 264995 | Vibrio cholerae, strain CVD 103-HgR, live | Vaccines | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 254598 | Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 | Vaccines | 2021-08 | Issued Notice of Compliance | 2022-02 |
| 219321 | Vitamin D3 | Vitamins | 2019-01 | Issued Notice of Compliance | 2021-02 |
| 225983 | Vitamin K1 | Antihemorrhagics | 2019-08 | Issued Notice of Deficiency - Withdrawal | 2021-06 |
| 209280 | Volanesorsen | Lipid modifying agents | 2017-11 | Issued Notice of Non-compliance - Withdrawal | 2018-11 |
| 213188 | Vonicog alfa | Antihemorrhagics | 2018-03 | Issued Notice of Compliance | 2019-01 |
| 282910 | Vorasidenib citrate | Antineoplastic agents | 2024-03 | Issued Notice of Compliance | 2024-08 |
| 233097 | Voretigene neparvovec | Ophthalmologicals | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 267923 | Vutrisiran | Other nervous system drugs | 2022-12 | Issued Notice of Compliance | 2023-10 |
| 254518 | Whole virion inactivated coronavirus *For use in relation to COVID-19 | Vaccines | 2021-07 | Cancelled by sponsor | 2022-08 |
| 242748 | Zanubrutinib | Antineoplastic agents | 2020-09 | Issued Notice of Compliance | 2021-03 |
| 242885 | Zanubrutinib | Antineoplastic agents | 2020-09 | Issued Notice of Compliance | 2021-07 |
| 276757 | Zilucoplan | Immunosuppressants | 2023-08 | Issued Notice of Compliance | 2024-07 |
| 212392 | Zofenopril calcium | Agents acting on the renin-angiotensin system | 2018-06 | Cancelled by sponsor | 2019-06 |
| 282144 | Zolbetuximab | Antineoplastic agents | 2024-02 | Issued Notice of Compliance | 2024-12 |
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