Drug and Health Product Submissions Under Review (SUR): Supplemental 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 SubmissionFootnote a (Hyperlinked if applicable) |
Year, Month Submission Concluded |
|---|---|---|---|---|---|
| 208070 | Abacavir sulfate, dolutegravir sodium, lamivudine | Antivirals for systemic use | 2017-08 | Issued Notice of Compliance | 2017-10 |
| 204313 | Abatacept | Immunosuppressants | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 255926 | Abatacept | Immunosuppressants | 2021-09 | Issued Notice of Compliance | 2022-07 |
| 249557 | Abemaciclib | Antineoplastic agents | 2021-03 | Issued Notice of Compliance | 2022-01 |
| 270898 | Abemaciclib | Antineoplastic agents | 2023-03 | Issued Notice of Compliance | 2023-12 |
| 207915 | Abiraterone acetate | Endocrine therapy | 2017-08 | Issued Notice of Compliance | 2018-02 |
| 202245 | Abobotulinumtoxina | Muscle relaxants | 2017-03 | Issued Notice of Compliance | 2017-12 |
| 204299 | Abobotulinumtoxina | Muscle relaxants | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 206921 | Abobotulinumtoxina | Muscle relaxants | 2017-08 | Issued Notice of Compliance | 2018-04 |
| 236999 | Abobotulinumtoxina | Muscle relaxants | 2020-04 | Issued Notice of Compliance | 2021-02 |
| 231228 | Acalabrutinib | Antineoplastic agents | 2019-10 | Issued Notice of Compliance | 2019-11 |
| 259715 | Ad26.COV2.S (recombinant) *For use in relation to COVID-19 | Vaccines | 2021-12 | Issued Notice of Compliance | 2022-05 |
| 197529 | Adalimumab | Immunosuppressants | 2016-09 | Issued Notice of Compliance | 2017-07 |
| 201423 | Adalimumab | Immunosuppressants | 2017-02 | Issued Notice of Compliance | 2017-12 |
| 212133 | Adalimumab | Immunosuppressants | 2018-02 | Issued Notice of Compliance | 2018-11 |
| 213550 | Adalimumab | Immunosuppressants | 2018-03 | Issued Notice of Compliance | 2019-01 |
| 219453 | Adalimumab | Immunosuppressants | 2018-10 | Issued Notice of Compliance | 2020-11 |
| 234183 | Adalimumab | Immunosuppressants | 2019-12 | Issued Notice of Compliance | 2020-11 |
| 234258 | Adalimumab | Immunosuppressants | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 239280 | Adalimumab | Immunosuppressants | 2020-06 | Issued Notice of Compliance | 2021-04 |
| 244618 | Adalimumab | Immunosuppressants | 2020-11 | Issued Notice of Compliance | 2021-09 |
| 257327 | Adalimumab | Immunosuppressants | 2021-11 | Issued Notice of Compliance | 2022-08 |
| 256159 | Adalimumab | Immunosuppressants | 2021-10 | Issued Notice of Compliance | 2022-09 |
| 258125 | Adalimumab | Immunosuppressants | 2021-12 | Issued Notice of Compliance | 2022-10 |
| 259979 | Adalimumab | Immunosuppressants | 2022-02 | Issued Notice of Compliance | 2022-11 |
| 282461 | Adalimumab | Immunosuppressants | 2024-03 | Issued Notice of Compliance | 2025-01 |
| 209785 | Afatinib dimaleate | Antineoplastic agents | 2017-12 | Issued Notice of Compliance | 2018-09 |
| 210816 | Alectinib | Antineoplastic agents | 2017-12 | Issued Notice of Compliance | 2018-06 |
| 282375 | Alectinib hydrochloride | Antineoplastic agents | 2024-01 | Issued Notice of Compliance | 2024-06 |
| 239220 | Alemtuzumab | Immunosuppressants | 2020-07 | Issued Notice of Compliance | 2021-04 |
| 219669 | Alirocumab | Lipid modifying agents | 2018-10 | Issued Notice of Compliance | 2019-07 |
| 205855 | Alpha 1-proteinase inhibitor (human) | Antihemorrhagics | 2017-06 | Issued Notice of Compliance | 2017-06 |
| 282121 | Amivantamab | Antineoplastic agents | 2024-01 | Issued Notice of Compliance | 2024-06 |
| 283969 | Amivantamab | Antineoplastic agents | 2024-03 | Issued Notice of Compliance | 2025-01 |
| 195649 | Anakinra | Immunosuppressants | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 237738 | Anakinra | Immunosuppressants | 2020-05 | Cancelled by sponsor | 2021-10 |
| 262044 | Anidulafungin | Antimycotics for systemic use | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 234257 | Anthrax antigen filtrate | Vaccines | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 250002 | Antihemophilic factor (recombinant) | Antihemorrhagics | 2021-03 | Issued Notice of Compliance | 2022-01 |
| 211971 | Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 2018-01 | Issued Notice of Compliance | 2018-11 |
| 245031 | Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 2020-11 | Issued Notice of Compliance | 2021-11 |
| 268221 | Antihemophilic factor VIII (recombinant, B-domain truncated), pegylated | Antihemorrhagics | 2022-11 | Issued Notice of Compliance | 2023-09 |
| 228077 | Apalutamide | Endocrine therapy | 2019-06 | Issued Notice of Compliance | 2019-12 |
| 198842 | Apixaban | Antithrombotic agents | 2016-11 | Issued Notice of Compliance | 2018-10 |
| 233030 | Apremilast | Immunosuppressants | 2019-12 | Issued Notice of Compliance | 2020-08 |
| 200292 | Aripiprazole | Psycholeptics | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 266917 | Aripiprazole | Psycholeptics | 2022-09 | Issued Notice of Compliance | 2025-01 |
| 278283 | Atenolol | Beta blocking agents | 2023-09 | Issued Notice of Compliance | 2024-01 |
| 279029 | Atenolol | Beta blocking agents | 2023-10 | Issued Notice of Compliance | 2024-02 |
| 278032 | Atenolol | Beta blocking agents | 2023-09 | Issued Notice of Compliance | 2024-02 |
| 205038 | Atezolizumab | Antineoplastic agents | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 217324 | Atezolizumab | Antineoplastic agents | 2018-07 | Issued Notice of Compliance | 2019-05 |
| 223753 | Atezolizumab | Antineoplastic agents | 2019-02 | Issued Notice of Compliance | 2019-08 |
| 223911 | Atezolizumab | Antineoplastic agents | 2019-02 | Issued Notice of Compliance under the NOC/c Guidance | 2019-09 |
| 226905 | Atezolizumab | Antineoplastic agents | 2019-06 | Issued Notice of Compliance | 2020-04 |
| 235450 | Atezolizumab | Antineoplastic agents | 2020-02 | Issued Notice of Compliance | 2020-08 |
| 237371 | Atezolizumab | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 254361 | Atezolizumab | Antineoplastic agents | 2021-07 | Issued Notice of Compliance | 2022-01 |
| 254159 | Atezolizumab | Antineoplastic agents | 2021-08 | Issued Notice of Compliance | 2022-03 |
| 273484 | Atogepant | Analgesics | 2023-07 | Issued Notice of Compliance | 2024-05 |
| 225974 | Avelumab | Antineoplastic agents | 2019-04 | Issued Notice of Compliance under the NOC/c Guidance | 2019-11 |
| 226954 | Avelumab | Antineoplastic agents | 2019-06 | Cancelled by sponsor | 2020-06 |
| 240024 | Avelumab | Antineoplastic agents | 2020-06 | Issued Notice of Compliance | 2020-12 |
| 256106 | Axicabtagene ciloleucel | Antineoplastic agents | 2021-10 | Issued Notice of Compliance under the NOC/c Guidance | 2022-09 |
| 259651 | Axicabtagene ciloleucel | Antineoplastic agents | 2022-02 | Issued Notice of Compliance | 2022-12 |
| 245813 | Axitinib | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 221498 | Azelastine hydrochloride, fluticasone propionate | Nasal preparations | 2018-12 | Issued Notice of Compliance | 2019-10 |
| 254371 | Azelastine hydrochloride, fluticasone propionate | Nasal preparations | 2021-08 | Issued Notice of Compliance | 2022-05 |
| 245874 | Baricitinib | Immunosuppressants | 2020-12 | Cancelled by sponsor | 2022-01 |
| 270684 | Baricitinib | Immunosuppressants | 2023-04 | Issued Notice of Compliance | 2024-01 |
| 256724 | Baricitinib *For use in relation to COVID-19 | Immunosuppressants | 2021-10 | Issued Notice of Non-compliance - Withdrawal | 2023-06 |
| 210469 | Bazedoxifene acetate, conjugated estrogens | Sex hormones and modulators of the genital system | 2017-11 | Issued Notice of Compliance | 2018-09 |
| 243390 | Belimumab | Immunosuppressants | 2020-10 | Issued Notice of Compliance | 2021-07 |
| 270609 | Belzutifan | Antineoplastic agents | 2023-01 | Issued Notice of Compliance | 2023-07 |
| 282593 | Belzutifan | Antineoplastic agents | 2024-02 | Issued Notice of Compliance | 2024-12 |
| 247673 | Betamethasone dipropionate, calcipotriol monohydrate | Corticosteroids, dermatological preparations | 2021-01 | Issued Notice of Compliance | 2021-10 |
| 207259 | Bevacizumab | Antineoplastic agents | 2017-08 | Issued Notice of Compliance | 2018-06 |
| 218844 | Bevacizumab | Antineoplastic agents | 2018-09 | Issued Notice of Compliance | 2019-06 |
| 230254 | Bevacizumab | Antineoplastic agents | 2019-09 | Issued Notice of Compliance | 2020-02 |
| 232977 | Bevacizumab | Antineoplastic agents | 2019-11 | Issued Notice of Compliance | 2021-01 |
| 257734 | Bevacizumab | Antineoplastic agents | 2021-12 | Issued Notice of Compliance | 2022-10 |
| 259936 | Bevacizumab | Antineoplastic agents | 2022-02 | Issued Notice of Compliance | 2022-11 |
| 226658 | Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 240953 | Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2020-07 | Issued Notice of Compliance | 2021-05 |
| 241318 | Bilastine | Antihistamines for systemic use | 2020-10 | Issued Notice of Compliance | 2021-08 |
| 273184 | Bimekizumab | Immunosuppressants | 2023-05 | Issued Notice of Compliance | 2024-02 |
| 273663 | Bimekizumab | Immunosuppressants | 2023-05 | Issued Notice of Compliance | 2024-03 |
| 243497 | Bisoprolol fumarate | Beta blocking agents | 2021-01 | Issued Notice of Compliance | 2024-01 |
| 197615 | Blinatumomab | Antineoplastic agents | 2016-09 | Issued Notice of Compliance under the NOC/c Guidance | 2017-04 |
| 204154 | Blinatumomab | Antineoplastic agents | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 210780 | Blinatumomab | Antineoplastic agents | 2017-12 | Issued Notice of Compliance under the NOC/c Guidance | 2019-12 |
| 283004 | Blinatumomab | Antineoplastic agents | 2024-02 | Issued Notice of Compliance | 2024-12 |
| 211317 | Bosutinib | Antineoplastic agents | 2018-02 | Issued Notice of Compliance | 2018-12 |
| 213996 | Brentuximab vedotin | Antineoplastic agents | 2018-04 | Issued Notice of Compliance | 2018-12 |
| 216513 | Brentuximab vedotin | Antineoplastic agents | 2018-07 | Issued Notice of Compliance | 2019-05 |
| 227030 | Brentuximab vedotin | Antineoplastic agents | 2019-05 | Issued Notice of Compliance | 2019-11 |
| 268334 | Brentuximab vedotin | Antineoplastic agents | 2022-12 | Cancelled by sponsor | 2023-09 |
| 205854 | Brexpiprazole | Psycholeptics | 2017-07 | Issued Notice of Compliance | 2019-02 |
| 257995 | Brexpiprazole | Psycholeptics | 2021-12 | Cancelled by sponsor | 2022-06 |
| 272694 | Brexpiprazole | Psycholeptics | 2023-04 | Issued Notice of Compliance | 2024-01 |
| 262249 | Brexucabtagene autoleucel | Antineoplastic agents | 2022-04 | Issued Notice of Compliance | 2022-11 |
| 237680 | Brigatinib | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 226734 | Brivaracetam | Antiepileptics | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 259754 | Brolucizumab | Ophthalmologicals | 2022-02 | Issued Notice of Compliance | 2022-11 |
| 218994 | Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2018-09 | Cancelled by sponsor | 2020-03 |
| 238101 | Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 220998 | Budesonide, formoterol fumarate dihydrate | Drugs for obstructive airway diseases | 2018-11 | Issued Notice of Compliance | 2019-09 |
| 229313 | Burosumab | Drugs for treatment of bone diseases | 2019-08 | Issued Notice of Compliance | 2020-06 |
| 249112 | Burosumab | Drugs for treatment of bone diseases | 2021-03 | Issued Notice of Compliance | 2021-08 |
| 197440 | C1 esterase inhibitor (human) | Other hematological agents | 2016-09 | Issued Notice of Compliance | 2017-03 |
| 254233 | Cabotegravir, rilpivirine | Antivirals for systemic use | 2021-08 | Issued Notice of Compliance | 2022-06 |
| 258574 | Cabotegravir, rilpivirine | Antivirals for systemic use | 2022-02 | Issued Notice of Compliance | 2022-12 |
| 221859 | Cabozantinib | Antineoplastic agents | 2018-12 | Issued Notice of Compliance | 2019-10 |
| 222733 | Cabozantinib | Antineoplastic agents | 2019-01 | Issued Notice of Compliance | 2019-11 |
| 245824 | Cabozantinib | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 257143 | Cabozantinib malate | Antineoplastic agents | 2021-11 | Issued Notice of Compliance | 2022-04 |
| 280615 | Cabozantinib malate | Antineoplastic agents | 2023-11 | Issued Notice of Compliance | 2024-09 |
| 194762 | Canagliflozin | Drugs used in diabetes | 2016-06 | Issued Notice of Compliance | 2017-04 |
| 210676 | Canagliflozin | Drugs used in diabetes | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 229188 | Canagliflozin | Drugs used in diabetes | 2019-08 | Issued Notice of Compliance | 2020-01 |
| 210969 | Canagliflozin, metformin hydrochloride | Drugs used in diabetes | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 232307 | Canagliflozin, metformin hydrochloride | Drugs used in diabetes | 2019-11 | Issued Notice of Compliance | 2020-08 |
| 195617 | Canakinumab | Immunosuppressants | 2016-07 | Issued Notice of Compliance | 2017-01 |
| 237113 | Canakinumab | Immunosuppressants | 2020-04 | Issued Notice of Compliance | 2021-02 |
| 225949 | Carbetocin | Pituitary and hypothalamic hormones and analogues | 2019-05 | Issued Notice of Compliance | 2020-02 |
| 237196 | Carfilzomib | Antineoplastic agents | 2020-04 | Issued Notice of Compliance | 2021-01 |
| 267413 | Carfilzomib | Antineoplastic agents | 2022-10 | Issued Notice of Compliance | 2023-07 |
| 227936 | Carglumic acid | Other alimentary tract and metabolism products | 2019-06 | Issued Notice of Compliance | 2020-11 |
| 224729 | Ceftolozane, tazobactam sodium | Antibacterials for systemic use | 2019-03 | Issued Notice of Compliance | 2019-08 |
| 246918 | Cemiplimab | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 256178 | Cemiplimab | Antineoplastic agents | 2021-09 | Issued Notice of Compliance | 2022-03 |
| 263700 | Cemiplimab | Antineoplastic agents | 2022-05 | Issued Notice of Compliance | 2023-04 |
| 209082 | Certolizumab pegol | Immunosuppressants | 2017-10 | Issued Notice of Compliance | 2018-08 |
| 222049 | Certolizumab pegol | Immunosuppressants | 2019-01 | Issued Notice of Compliance | 2019-11 |
| 259446 | ChAdOx1-S (recombinant) *For use in relation to COVID-19 | Vaccines | 2021-12 | Cancelled by sponsor | 2022-03 |
| 265382 | Cilgavimab, tixagevimab *For use in relation to COVID-19 | Immune sera and immunoglobulins | 2022-06 | Issued Notice of Compliance | 2022-10 |
| 277017 | Ciltacabtagene autoleucel | Antineoplastic agents | 2023-08 | Issued Notice of Compliance | 2024-07 |
| 258126 | Coagulation factor IX (recombinant), pegylated | Antihemorrhagics | 2021-12 | Issued Notice of Compliance | 2022-10 |
| 274244 | Coagulation factor VIII (human), human plasma proteins, Von Willebrand factor (human) | Antihemorrhagics | 2023-05 | Issued Notice of Compliance | 2024-02 |
| 195789 | Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 207251 | Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2017-08 | Issued Notice of Compliance | 2018-06 |
| 219784 | Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 2018-10 | Issued Notice of Compliance | 2019-07 |
| 202488 | Collagenase clostridium histolyticum | Other drugs for disorders of the musculo-skeletal system | 2017-03 | Issued Notice of Compliance | 2018-01 |
| 285411 | Concizumab | Antihemorrhagics | 2024-05 | Cancelled by sponsor | 2024-06 |
| 216208 | Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F | Vaccines | 2018-06 | Issued Notice of Compliance | 2019-04 |
| 270922 | Corynebacterium diphtheriae 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 | 2023-01 | Issued Notice of Compliance | 2023-07 |
| 259725 | Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F | Vaccines | 2022-01 | Issued Notice of Compliance | 2022-07 |
| 240171 | Crisaborole | Other dermatological preparations | 2020-07 | Issued Notice of Compliance | 2021-05 |
| 198322 | Crizotinib | Antineoplastic agents | 2016-11 | Issued Notice of Compliance | 2017-08 |
| 199381 | Dabrafenib | Antineoplastic agents | 2016-11 | Issued Notice of Compliance | 2017-05 |
| 210753 | Dabrafenib | Antineoplastic agents | 2017-11 | Issued Notice of Compliance | 2018-05 |
| 213581 | Dabrafenib | Antineoplastic agents | 2018-03 | Issued Notice of Compliance | 2018-09 |
| 270381 | Dabrafenib mesylate | Antineoplastic agents | 2023-01 | Issued Notice of Compliance | 2023-07 |
| 278103 | Dalbavancin | Antibacterials for systemic use | 2023-09 | Issued Notice of Compliance | 2024-07 |
| 227213 | Dapagliflozin propanediol | Drugs used in diabetes | 2019-06 | Issued Notice of Compliance | 2020-04 |
| 234304 | Dapagliflozin propanediol | Drugs used in diabetes | 2020-01 | Issued Notice of Compliance | 2020-06 |
| 248367 | Dapagliflozin propanediol | Drugs used in diabetes | 2021-02 | Issued Notice of Compliance | 2021-08 |
| 268982 | Dapagliflozin propanediol monohydrate | Drugs used in diabetes | 2022-12 | Issued Notice of Compliance | 2023-10 |
| 228055 | Dapagliflozin, metformin hydrochloride | Drugs used in diabetes | 2019-07 | Issued Notice of Compliance | 2020-04 |
| 214792 | Daptomycin | Antibacterials for systemic use | 2018-05 | Issued Notice of Compliance | 2019-02 |
| 198647 | Daratumumab | Antineoplastic agents | 2016-10 | Issued Notice of Compliance | 2017-04 |
| 212559 | Daratumumab | Antineoplastic agents | 2018-01 | Issued Notice of Compliance | 2018-11 |
| 226512 | Daratumumab | Antineoplastic agents | 2019-05 | Issued Notice of Compliance | 2019-10 |
| 234407 | Daratumumab | Antineoplastic agents | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 244119 | Daratumumab | Antineoplastic agents | 2020-11 | Issued Notice of Compliance | 2021-04 |
| 249815 | Daratumumab | Antineoplastic agents | 2021-03 | Issued Notice of Compliance | 2022-01 |
| 259880 | Daratumumab | Antineoplastic agents | 2022-02 | Issued Notice of Compliance | 2022-12 |
| 286426 | Daratumumab | Antineoplastic agents | 2024-05 | Issued Notice of Compliance | 2024-11 |
| 262749 | Darolutamide | Endocrine therapy | 2022-04 | Issued Notice of Compliance | 2022-09 |
| 273747 | Davesomeran, elasomeran *For use in relation to COVID-19 | Vaccines | 2023-03 | Issued Notice of Compliance | 2023-05 |
| 274717 | Davesomeran, elasomeran *For use in relation to COVID-19 | Vaccines | 2023-05 | Cancelled by sponsor | 2023-10 |
| 244597 | Deferiprone | All other therapeutic products | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 261912 | Deferiprone | All other therapeutic products | 2022-06 | Issued Notice of Compliance | 2023-03 |
| 203717 | Denosumab | Drugs for treatment of bone diseases | 2017-04 | Issued Notice of Compliance | 2018-02 |
| 205235 | Denosumab | Drugs for treatment of bone diseases | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 241617 | Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | 2020-09 | Issued Notice of Compliance | 2022-12 |
| 285056 | Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | 2024-05 | Issued Notice of Compliance | 2025-03 |
| 215955 | Dexlansoprazole | Drugs for acid related disorders | 2018-06 | Issued Notice of Compliance | 2019-04 |
| 259869 | Dimethyl fumarate | Immunosuppressants | 2022-04 | Issued Notice of Compliance | 2023-05 |
| 243463 | Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, inactivated poliovirus type I, inactivated poliovirus type II, inactivated poliovirus type III, pertactin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed | Vaccines | 2020-10 | Issued Notice of Compliance | 2021-08 |
| 243456 | Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed | Vaccines | 2020-10 | Issued Notice of Compliance | 2021-08 |
| 220233 | Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), inactivated poliomyelitis vaccine (D.C.O) Type 1 Mahoney, inactivated poliomyelitis vaccine (D.C.O) Type 2 M.E.F.1, inactivated poliomyelitis vaccine (D.C.O) Type 3 Saukett, pertactin, pertussis toxoid, tetanus toxoid | Vaccines | 2018-11 | Issued Notice of Compliance | 2020-09 |
| 220103 | Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid | Vaccines | 2018-11 | Issued Notice of Compliance | 2020-09 |
| 207076 | Dolutegravir | Antivirals for systemic use | 2017-08 | Issued Notice of Compliance | 2018-05 |
| 235583 | Dolutegravir | Antivirals for systemic use | 2020-04 | Issued Notice of Compliance | 2021-01 |
| 264733 | Doravirine | Antivirals for systemic use | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 266249 | Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | 2022-09 | Issued Notice of Compliance | 2023-07 |
| 274515 | Dostarlimab | Antineoplastic agents | 2023-05 | Issued Notice of Compliance | 2023-11 |
| 201964 | Dulaglutide | Drugs used in diabetes | 2017-03 | Issued Notice of Compliance | 2017-12 |
| 232128 | Dulaglutide | Drugs used in diabetes | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 221043 | Dupilumab | Other dermatological preparations | 2018-11 | Issued Notice of Compliance | 2019-09 |
| 231268 | Dupilumab | Other dermatological preparations | 2019-10 | Issued Notice of Compliance | 2020-08 |
| 234105 | Dupilumab | Other dermatological preparations | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 237081 | Dupilumab | Other dermatological preparations | 2023-03 | Issued Notice of Compliance | 2021-02 |
| 252306 | Dupilumab | Other dermatological preparations | 2021-05 | Issued Notice of Compliance | 2022-03 |
| 264439 | Dupilumab | Other dermatological preparations | 2022-06 | Issued Notice of Compliance | 2023-04 |
| 268311 | Dupilumab | Other dermatological preparations | 2022-11 | Issued Notice of Compliance | 2023-05 |
| 266537 | Dupilumab | Other dermatological preparations | 2022-09 | Issued Notice of Compliance | 2023-07 |
| 283782 | Dupilumab | Other dermatological preparations | 2024-03 | Issued Notice of Compliance | 2024-09 |
| 233107 | Durvalumab | Antineoplastic agents | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 262782 | Durvalumab | Antineoplastic agents | 2022-04 | Issued Notice of Compliance | 2022-09 |
| 281318 | Durvalumab | Endocrine therapy | 2024-01 | Issued Notice of Compliance | 2024-10 |
| 282097 | Durvalumab | Antineoplastic agents | 2024-01 | Issued Notice of Compliance | 2025-01 |
| 212987 | Eculizumab | Immunosuppressants | 2018-02 | Issued Notice of Compliance | 2018-08 |
| 225847 | Eculizumab | Immunosuppressants | 2019-04 | Issued Notice of Compliance | 2019-09 |
| 253430 | Elasomeran *For use in relation to COVID-19 | Vaccines | 2021-06 | Authorized under Interim Order | 2021-08 |
| 257293 | Elasomeran *For use in relation to COVID-19 | Vaccines | 2021-10 | Issued Notice of Compliance | 2021-11 |
| 258658 | Elasomeran *For use in relation to COVID-19 | Vaccines | 2021-11 | Issued Notice of Compliance | 2022-03 |
| 263775 | Elasomeran *For use in relation to COVID-19 | Vaccines | 2022-04 | Issued Notice of Compliance | 2022-07 |
| 262952 | Elasomeran *For use in relation to COVID-19 | Vaccines | 2022-04 | Cancelled by sponsor | 2022-09 |
| 262408 | Elasomeran *For use in relation to COVID-19 | Vaccines | 2022-03 | Issued Notice of Compliance | 2023-01 |
| 269428 | Elasomeran, imelasomeran *For use in relation to COVID-19 | Vaccines | 2022-11 | Issued Notice of Compliance | 2023-02 |
| 255136 | Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 2021-10 | Issued Notice of Compliance | 2022-04 |
| 271750 | Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 2023-04 | Issued Notice of Compliance | 2023-10 |
| 282009 | Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 2024-01 | Issued Notice of Compliance | 2024-07 |
| 195798 | Eltrombopag olamine | Antihemorrhagics | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 217802 | Eltrombopag olamine | Antihemorrhagics | 2018-07 | Issued Notice of Compliance | 2019-05 |
| 216004 | Eltrombopag olamine | Antihemorrhagics | 2018-06 | Cancelled by sponsor | 2019-06 |
| 222209 | Emicizumab | Antihemorrhagics | 2018-12 | Issued Notice of Compliance | 2019-06 |
| 193840 | Empagliflozin | Drugs used in diabetes | 2016-05 | Issued Notice of Compliance | 2018-04 |
| 221628 | Empagliflozin | Drugs used in diabetes | 2019-01 | Issued Notice of Compliance | 2019-04 |
| 246457 | Empagliflozin | Drugs used in diabetes | 2021-01 | Issued Notice of Compliance | 2021-10 |
| 256491 | Empagliflozin | Drugs used in diabetes | 2021-10 | Issued Notice of Compliance | 2022-04 |
| 270652 | Empagliflozin | Drugs used in diabetes | 2023-03 | Issued Notice of Compliance | 2024-01 |
| 204589 | Empagliflozin, linagliptin | Drugs used in diabetes | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 234525 | Emtricitabine, tenofovir alafenamide | Antivirals for systemic use | 2020-02 | Issued Notice of Compliance | 2020-11 |
| 283003 | Enfortumab vedotin | Antineoplastic agents | 2024-02 | Issued Notice of Compliance | 2024-08 |
| 209807 | Enoxaparin sodium | Antithrombotic agents | 2017-11 | Issued Notice of Compliance | 2018-09 |
| 216719 | Enzalutamide | Endocrine therapy | 2018-06 | Issued Notice of Compliance | 2018-12 |
| 233563 | Enzalutamide | Endocrine therapy | 2019-12 | Issued Notice of Compliance | 2020-06 |
| 277282 | Enzalutamide | Endocrine therapy | 2023-08 | Issued Notice of Compliance | 2024-01 |
| 200866 | Eptacog alfa | Antihemorrhagics | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 267878 | Eptacog alfa | Antihemorrhagics | 2022-11 | Cancelled by sponsor | 2023-03 |
| 197739 | Eribulin mesylate | Antineoplastic agents | 2016-10 | Issued Notice of Compliance | 2017-08 |
| 194018 | Erlotinib hydrochloride | Antineoplastic agents | 2016-06 | Issued Notice of Compliance | 2017-03 |
| 244338 | Esketamine hydrochloride | Psychoanaleptics | 2020-11 | Issued Notice of Compliance | 2021-09 |
| 208086 | Eslicarbazepine acetate | Antiepileptics | 2017-09 | Issued Notice of Compliance | 2018-06 |
| 209753 | Eslicarbazepine acetate | Antiepileptics | 2017-11 | Issued Notice of Compliance | 2018-09 |
| 193787 | Etanercept | Immunosuppressants | 2016-05 | Issued Notice of Compliance | 2017-03 |
| 213347 | Etanercept | Immunosuppressants | 2018-03 | Issued Notice of Compliance | 2019-01 |
| 226145 | Etanercept | Immunosuppressants | 2019-05 | Issued Notice of Compliance | 2020-06 |
| 231313 | Etanercept | Immunosuppressants | 2019-10 | Issued Notice of Compliance | 2020-08 |
| 200814 | Everolimus | Antineoplastic agents | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 207038 | Evolocumab | Lipid modifying agents | 2017-08 | Issued Notice of Compliance | 2018-06 |
| 208904 | Evolocumab | Lipid modifying agents | 2017-10 | Issued Notice of Compliance | 2018-08 |
| 247936 | Evolocumab | Lipid modifying agents | 2021-02 | Issued Notice of Compliance | 2021-12 |
| 208034 | Exenatide | Drugs used in diabetes | 2017-09 | Issued Notice of Compliance | 2018-07 |
| 268826 | Famtozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | 2022-10 | Issued Notice of Compliance | 2022-12 |
| 274152 | Famtozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | 2023-03 | Issued Notice of Compliance | 2023-07 |
| 275559 | Famtozinameran, tozinameran *For use in relation to COVID-19 | Vaccines | 2023-06 | Issued Notice of Compliance | 2023-08 |
| 278042 | Faricimab | Ophthalmologicals | 2023-09 | Issued Notice of Compliance | 2024-07 |
| 230407 | Fibrinogen (human) | Antihemorrhagics | 2019-09 | Issued Notice of Compliance | 2020-07 |
| 227551 | Fibrinogen (human) | Antihemorrhagics | 2019-06 | Cancelled by sponsor | 2020-11 |
| 281380 | Fibrinogen (human), thrombin (human) | Antihemorrhagics | 2024-01 | Issued Notice of Compliance | 2024-11 |
| 215423 | Fingolimod hydrochloride | Immunosuppressants | 2018-05 | Issued Notice of Compliance | 2018-11 |
| 229727 | Flibanserin | Other gynecologicals | 2019-07 | Issued Notice of Compliance | 2021-01 |
| 208727 | Fluticasone furoate | Drugs for obstructive airway diseases | 2017-10 | Cancelled by sponsor | 2018-10 |
| 215148 | Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 2018-05 | Issued Notice of Compliance | 2019-03 |
| 240101 | Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 2020-07 | Issued Notice of Compliance | 2021-05 |
| 239493 | Formoterol fumarate dihydrate, mometasone furoate | Drugs for obstructive airway diseases | 2020-06 | Issued Notice of Compliance | 2021-04 |
| 256308 | Fosfomycin sodium | Antibacterials for systemic use | 2021-12 | Issued Notice of Compliance | 2022-10 |
| 201150 | Fulvestrant | Endocrine therapy | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 205610 | Gadoterate meglumine | Contrast media | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 252254 | Gadoteridol | Contrast media | 2021-07 | Issued Notice of Compliance | 2022-05 |
| 232324 | Galcanezumab | Analgesics | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 279567 | Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | 2023-11 | Issued Notice of Compliance | 2024-09 |
| 222816 | Glecaprevir, pibrentasvir | Antivirals for systemic use | 2018-12 | Issued Notice of Compliance | 2019-06 |
| 247707 | Glecaprevir, pibrentasvir | Antivirals for systemic use | 2021-02 | Issued Notice of Compliance | 2021-11 |
| 259175 | Glycerol phenylbutyrate | Other alimentary tract and metabolism products | 2022-02 | Issued Notice of Compliance | 2022-11 |
| 198552 | Glycopyrronium bromide, indacaterol maleate | Drugs for obstructive airway diseases | 2016-11 | Issued Notice of Compliance | 2017-08 |
| 197362 | Golimumab | Immunosuppressants | 2016-09 | Issued Notice of Compliance | 2017-06 |
| 205724 | Golimumab | Immunosuppressants | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 255908 | Golimumab | Immunosuppressants | 2021-10 | Issued Notice of Compliance | 2022-07 |
| 275599 | Goserelin acetate | Endocrine therapy | 2023-07 | Issued Notice of Compliance | 2024-05 |
| 232124 | Guselkumab | Immunosuppressants | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 199807 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | 2016-11 | Issued Notice of Compliance | 2017-05 |
| 225528 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2019-04 | Issued Notice of Compliance | 2020-02 |
| 229325 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2019-08 | Issued Notice of Compliance | 2020-06 |
| 238479 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 246936 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2021-01 | Issued Notice of Compliance | 2021-11 |
| 251147 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 2021-05 | Issued Notice of Compliance | 2022-03 |
| 218188 | Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) | Vaccines | 2018-08 | Cancelled by sponsor | 2019-06 |
| 273436 | Hexaminolevulinate hydrochloride | Diagnostic agents | 2023-05 | Issued Notice of Compliance | 2024-03 |
| 208033 | Human immunoglobulin | Immune sera and immunoglobulins | 2017-09 | Issued Notice of Compliance | 2018-07 |
| 276884 | Hyaluronidase (human recombinant), immunoglobulin (human) | Immune sera and immunoglobulins | 2023-08 | Issued Notice of Compliance | 2024-06 |
| 276541 | Hyaluronidase (human recombinant), immunoglobulin (human) | Immune sera and immunoglobulins | 2023-08 | Issued Notice of Compliance | 2025-03 |
| 223245 | Hydromorphone hydrochloride | Analgesics | 2019-01 | Issued Notice of Compliance | 2019-05 |
| 223031 | Hydroxyethyl starch | Blood substitutes and perfusion solutions | 2019-04 | Issued Notice of Compliance | 2020-02 |
| 222938 | Hydroxyethyl starch | Blood substitutes and perfusion solutions | 2019-04 | Issued Notice of Compliance | 2020-02 |
| 226144 | Hydroxyurea | Antineoplastic agents | 2019-04 | Issued Notice of Compliance | 2020-02 |
| 204436 | Ibrutinib | Immunosuppressants | 2017-05 | Issued Notice of Compliance | 2017-10 |
| 212632 | Ibrutinib | Antineoplastic agents | 2018-02 | Issued Notice of Compliance | 2018-07 |
| 218457 | Ibrutinib | Antineoplastic agents | 2018-08 | Issued Notice of Compliance | 2019-02 |
| 222804 | Ibrutinib | Antineoplastic agents | 2019-01 | Issued Notice of Compliance | 2019-11 |
| 235706 | Ibrutinib | Antineoplastic agents | 2020-02 | Issued Notice of Compliance | 2020-12 |
| 263702 | Ibrutinib | Antineoplastic agents | 2022-05 | Issued Notice of Compliance | 2023-03 |
| 266710 | Ibrutinib | Antineoplastic agents | 2022-10 | Issued Notice of Compliance | 2023-08 |
| 217805 | Icatibant acetate | Other hematological agents | 2018-09 | Issued Notice of Compliance | 2019-06 |
| 203513 | Idelalisib | Antineoplastic agents | 2017-04 | Cancelled by sponsor | 2017-12 |
| 201326 | Immunoglobulin (human) | Immune sera and immunoglobulins | 2017-01 | Issued Notice of Compliance | 2017-10 |
| 223557 | Immunoglobulin (human) | Immune sera and immunoglobulins | 2019-02 | Cancelled by sponsor | 2019-11 |
| 240691 | Immunoglobulin (human) | Immune sera and immunoglobulins | 2020-07 | Issued Notice of Compliance | 2021-05 |
| 253256 | Immunoglobulin (human) | Immune sera and immunoglobulins | 2021-07 | Issued Notice of Compliance | 2022-05 |
| 208713 | Incobotulinumtoxina | Muscle relaxants | 2017-10 | Issued Notice of Compliance | 2019-06 |
| 234438 | Incobotulinumtoxina | Muscle relaxants | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 251521 | Incobotulinumtoxina | Muscle relaxants | 2021-05 | Issued Notice of Compliance | 2022-03 |
| 257192 | Incobotulinumtoxina | Muscle relaxants | 2021-11 | Issued Notice of Compliance | 2022-09 |
| 268590 | Incobotulinumtoxina | Muscle relaxants | 2022-11 | Cancelled by sponsor | 2023-10 |
| 278522 | Incobotulinumtoxina | Muscle relaxants | 2023-10 | Issued Notice of Compliance | 2024-12 |
| 220321 | Infliximab | Immunosuppressants | 2018-11 | Issued Notice of Compliance | 2019-08 |
| 236086 | Infliximab | Immunosuppressants | 2020-04 | Issued Notice of Compliance | 2021-01 |
| 262141 | Infliximab | Immunosuppressants | 2022-04 | Issued Notice of Compliance | 2023-03 |
| 272981 | Infliximab | Immunosuppressants | 2023-04 | Issued Notice of Compliance | 2024-02 |
| 226586 | Insulin aspart | Drugs used in diabetes | 2019-05 | Issued Notice of Compliance | 2020-02 |
| 254352 | Insulin aspart | Drugs used in diabetes | 2021-10 | Issued Notice of Compliance | 2022-07 |
| 208917 | Insulin degludec | Drugs used in diabetes | 2017-10 | Issued Notice of Compliance | 2018-07 |
| 234406 | Insulin degludec, liraglutide | Drugs used in diabetes | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 228382 | Insulin glargine | Drugs used in diabetes | 2019-07 | Issued Notice of Compliance | 2020-05 |
| 232504 | Insulin glargine, lixisenatide | Drugs used in diabetes | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 268527 | Iohexol | Contrast media | 2023-03 | Issued Notice of Compliance | 2023-12 |
| 202533 | Ipilimumab | Antineoplastic agents | 2017-02 | Issued Notice of Compliance | 2017-04 |
| 255450 | Ipilimumab | Antineoplastic agents | 2021-09 | Issued Notice of Compliance | 2022-03 |
| 270801 | Ipilimumab | Antineoplastic agents | 2023-02 | Issued Notice of Compliance | 2023-12 |
| 244601 | Isatuximab | Antineoplastic agents | 2020-10 | Issued Notice of Compliance | 2021-09 |
| 280928 | Isavuconazonium sulfate | Antimycotics for systemic use | 2023-12 | Issued Notice of Compliance | 2024-11 |
| 218044 | Ivacaftor | Other respiratory system products | 2018-08 | Issued Notice of Compliance | 2019-01 |
| 247481 | Ivacaftor | Other respiratory system products | 2021-02 | Issued Notice of Compliance | 2021-08 |
| 255781 | Ivacaftor | Other respiratory system products | 2021-09 | Issued Notice of Compliance | 2022-03 |
| 273575 | Ivacaftor | Other respiratory system products | 2023-06 | Issued Notice of Compliance | 2023-11 |
| 198036 | Ivacaftor, lumacaftor | Other respiratory system products | 2016-10 | Issued Notice of Compliance | 2017-04 |
| 215032 | Ivacaftor, lumacaftor | Other respiratory system products | 2018-06 | Issued Notice of Compliance | 2018-12 |
| 264825 | Ivacaftor, lumacaftor | Other respiratory system products | 2022-07 | Issued Notice of Compliance | 2023-04 |
| 204690 | Ixekizumab | Immunosuppressants | 2017-06 | Issued Notice of Compliance | 2018-03 |
| 225178 | Ixekizumab | Immunosuppressants | 2019-04 | Issued Notice of Compliance | 2020-02 |
| 233071 | Ixekizumab | Immunosuppressants | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 238580 | Ixekizumab | Immunosuppressants | 2020-06 | Issued Notice of Compliance | 2021-03 |
| 203520 | Japanese encephalitis virus vaccine inactivated | Vaccines | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 193732 | Lacosamide | Antiepileptics | 2016-05 | Issued Notice of Compliance | 2017-02 |
| 203094 | Lanreotide acetate | Pituitary and hypothalamic hormones and analogues | 2017-04 | Issued Notice of Compliance | 2018-02 |
| 199607 | Ledipasvir, sofosbuvir | Antivirals for systemic use | 2016-11 | Issued Notice of Compliance | 2017-05 |
| 197794 | Lenvatinib mesylate | Antineoplastic agents | 2016-11 | Issued Notice of Compliance | 2017-09 |
| 212989 | Lenvatinib mesylate | Antineoplastic agents | 2018-02 | Issued Notice of Compliance | 2018-12 |
| 228723 | Lenvatinib mesylate | Antineoplastic agents | 2019-07 | Issued Notice of Compliance under the NOC/c Guidance | 2019-09 |
| 252195 | Lenvatinib mesylate | Antineoplastic agents | 2021-06 | Cancelled by sponsor | 2022-02 |
| 253057 | Lenvatinib mesylate | Antineoplastic agents | 2021-07 | Issued Notice of Compliance | 2022-05 |
| 272553 | Letermovir | Antivirals for systemic use | 2023-03 | Issued Notice of Compliance | 2023-09 |
| 276242 | Leucovorin calcium | All other therapeutic products | 2023-08 | Issued Notice of Compliance | 2023-12 |
| 193372 | Leuprolide acetate | Endocrine therapy | 2016-05 | Issued Notice of Compliance | 2017-02 |
| 269016 | Leuprolide acetate | Endocrine therapy | 2022-12 | Issued Notice of Compliance | 2023-09 |
| 254192 | Leuprolide acetate | Endocrine therapy | 2021-10 | Issued Notice of Compliance | 2024-01 |
| 222857 | Levomilnacipran | Psychoanaleptics | 2019-01 | Issued Notice of Compliance | 2019-11 |
| 204355 | Levonorgestrel | Sex hormones and modulators of the genital system | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 273103 | Levonorgestrel | Other gynecologicals | 2023-04 | Issued Notice of Compliance | 2024-02 |
| 279169 | Linaclotide | Drugs for constipation | 2023-11 | Issued Notice of Compliance | 2024-09 |
| 194075 | Linagliptin | Drugs used in diabetes | 2016-06 | Issued Notice of Compliance | 2018-10 |
| 222572 | Linagliptin | Drugs used in diabetes | 2019-01 | Issued Notice of Compliance | 2019-11 |
| 194067 | Linagliptin, metformin hydrochloride | Drugs used in diabetes | 2016-06 | Cancelled by sponsor | 2017-05 |
| 229225 | Linagliptin, metformin hydrochloride | Drugs used in diabetes | 2019-08 | Issued Notice of Compliance | 2020-06 |
| 196457 | Liraglutide | Drugs used in diabetes | 2016-08 | Issued Notice of Compliance | 2017-06 |
| 200821 | Liraglutide | Drugs used in diabetes | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 225809 | Liraglutide | Drugs used in diabetes | 2019-05 | Issued Notice of Compliance | 2020-02 |
| 237880 | Liraglutide | Drugs used in diabetes | 2020-05 | Issued Notice of Compliance | 2021-02 |
| 279827 | Lisocabtagene maraleucel | Antineoplastic agents | 2023-11 | Issued Notice of Compliance | 2024-09 |
| 247174 | Lorlatinib | Antineoplastic agents | 2021-01 | Issued Notice of Compliance | 2021-06 |
| 265088 | Lumasiran sodium | Other alimentary tract and metabolism products | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 197342 | Lurasidone hydrochloride | Psycholeptics | 2016-09 | Issued Notice of Compliance | 2017-07 |
| 205325 | Lurasidone hydrochloride | Psycholeptics | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 279552 | Luspatercept | Antianemic preparations | 2023-11 | Issued Notice of Compliance | 2024-09 |
| 282347 | Lutetium (177Lu) oxodotreotide | Therapeutic radiopharmaceuticals | 2024-02 | Issued Notice of Compliance | 2024-12 |
| 219599 | Macitentan | Antihypertensives | 2018-11 | Cancelled by sponsor | 2019-11 |
| 221389 | Macitentan | Antihypertensives | 2019-01 | Issued Notice of Compliance | 2020-07 |
| 272517 | Mavacamten | Cardiac therapy | 2023-04 | Issued Notice of Compliance | 2024-02 |
| 203844 | Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid | Vaccines | 2017-04 | Issued Notice of Compliance | 2018-02 |
| 208467 | Mepolizumab | Drugs for obstructive airway diseases | 2017-09 | Issued Notice of Compliance | 2018-07 |
| 212242 | Mepolizumab | Drugs for obstructive airway diseases | 2018-02 | Cancelled by sponsor | 2018-10 |
| 221528 | Mepolizumab | Drugs for obstructive airway diseases | 2018-12 | Issued Notice of Compliance | 2019-10 |
| 226197 | Mepolizumab | Drugs for obstructive airway diseases | 2019-05 | Issued Notice of Compliance | 2020-03 |
| 247542 | Mepolizumab | Drugs for obstructive airway diseases | 2021-01 | Issued Notice of Compliance | 2021-11 |
| 255153 | Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2021-09 | Issued Notice of Compliance | 2022-08 |
| 262828 | Methyl aminolevulinate hydrochloride | Antineoplastic agents | 2022-04 | Issued Notice of Compliance | 2023-02 |
| 214860 | Methylphenidate hydrochloride | Psychoanaleptics | 2018-05 | Issued Notice of Compliance | 2019-03 |
| 224342 | Methylphenidate hydrochloride | Psychoanaleptics | 2019-03 | Issued Notice of Compliance | 2020-01 |
| 210496 | Midostaurin | Antineoplastic agents | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 200856 | Mifepristone, misoprostol | Sex hormones and modulators of the genital system | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 262810 | Migalastat hydrochloride | Other alimentary tract and metabolism products | 2022-05 | Issued Notice of Compliance | 2023-03 |
| 195973 | Nadroparin calcium | Antithrombotic agents | 2016-08 | Issued Notice of Compliance | 2017-07 |
| 221031 | Naloxegol oxalate | Drugs for constipation | 2018-11 | Cancelled by sponsor | 2019-09 |
| 242449 | Neratinib maleate | Antineoplastic agents | 2020-09 | Issued Notice of Compliance | 2021-06 |
| 211052 | Nilotinib | Antineoplastic agents | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 227166 | Nintedanib | Antineoplastic agents | 2019-05 | Issued Notice of Compliance | 2019-11 |
| 232923 | Nintedanib | Antineoplastic agents | 2019-11 | Issued Notice of Compliance | 2020-05 |
| 241747 | Nintedanib | Antineoplastic agents | 2020-08 | Issued Notice of Compliance | 2021-06 |
| 237670 | Niraparib | Antineoplastic agents | 2020-04 | Issued Notice of Compliance | 2020-10 |
| 199379 | Nivolumab | Antineoplastic agents | 2016-11 | Issued Notice of Compliance | 2017-05 |
| 203286 | Nivolumab | Antineoplastic agents | 2017-03 | Issued Notice of Compliance | 2017-11 |
| 203593 | Nivolumab | Antineoplastic agents | 2017-04 | Cancelled by sponsor | 2018-01 |
| 206974 | Nivolumab | Antineoplastic agents | 2017-07 | Issued Notice of Compliance under the NOC/c Guidance | 2018-03 |
| 212067 | Nivolumab | Antineoplastic agents | 2018-01 | Issued Notice of Compliance | 2018-07 |
| 211838 | Nivolumab | Antineoplastic agents | 2018-01 | Issued Notice of Compliance | 2018-11 |
| 215535 | Nivolumab | Antineoplastic agents | 2018-06 | Cancelled by sponsor | 2019-11 |
| 236255 | Nivolumab | Antineoplastic agents | 2020-03 | Issued Notice of Compliance | 2020-08 |
| 234228 | Nivolumab | Antineoplastic agents | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 239474 | Nivolumab | Antineoplastic agents | 2020-06 | Issued Notice of Compliance under the NOC/c Guidance | 2021-02 |
| 243600 | Nivolumab | Antineoplastic agents | 2020-09 | Issued Notice of Compliance | 2021-05 |
| 247045 | Nivolumab | Antineoplastic agents | 2021-01 | Issued Notice of Compliance | 2021-07 |
| 245851 | Nivolumab | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 247339 | Nivolumab | Antineoplastic agents | 2021-01 | Issued Notice of Compliance | 2021-10 |
| 253652 | Nivolumab | Antineoplastic agents | 2021-07 | Issued Notice of Compliance under the NOC/c Guidance | 2022-06 |
| 257103 | Nivolumab | Antineoplastic agents | 2021-11 | Issued Notice of Compliance | 2022-07 |
| 261300 | Nivolumab | Antineoplastic agents | 2022-03 | Issued Notice of Compliance | 2022-08 |
| 272504 | Nivolumab | Antineoplastic agents | 2023-03 | Issued Notice of Compliance | 2023-12 |
| 282374 | Nivolumab | Antineoplastic agents | 2024-01 | Issued Notice of Compliance | 2024-06 |
| 208906 | Norfloxacin | Antibacterials for systemic use | 2017-10 | Issued Notice of Compliance | 2017-12 |
| 208089 | Obinutuzumab | Antineoplastic agents | 2017-09 | Issued Notice of Compliance | 2018-07 |
| 210204 | Olaparib | Antineoplastic agents | 2017-11 | Issued Notice of Compliance | 2018-05 |
| 219799 | Olaparib | Antineoplastic agents | 2018-11 | Issued Notice of Compliance | 2019-05 |
| 230309 | Olaparib | Antineoplastic agents | 2019-08 | Issued Notice of Compliance | 2020-02 |
| 235698 | Olaparib | Antineoplastic agents | 2020-02 | Issued Notice of Compliance | 2020-08 |
| 259417 | Olaparib | Antineoplastic agents | 2022-01 | Issued Notice of Compliance under the NOC/c Guidance | 2022-07 |
| 265427 | Olaparib | Antineoplastic agents | 2022-08 | Issued Notice of Compliance under the NOC/c Guidance | 2023-07 |
| 223910 | Olodaterol hydrochloride, tiotropium bromide monohydrate | Drugs for obstructive airway diseases | 2019-03 | Issued Notice of Compliance | 2019-12 |
| 194542 | Omalizumab | Drugs for obstructive airway diseases | 2016-06 | Issued Notice of Compliance | 2017-04 |
| 241064 | Omalizumab | Drugs for obstructive airway diseases | 2020-08 | Issued Notice of Compliance | 2021-07 |
| 195504 | Ombitasvir, paritaprevir, ritonavir | Antivirals for systemic use | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 211053 | OnabotulinumtoxinA | Muscle relaxants | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 237685 | OnabotulinumtoxinA | Muscle relaxants | 2020-05 | Issued Notice of Compliance | 2021-03 |
| 273166 | OnabotulinumtoxinA | Muscle relaxants | 2023-04 | Issued Notice of Compliance | 2024-02 |
| 275576 | OnabotulinumtoxinA | Muscle relaxants | 2023-06 | Cancelled by sponsor | 2024-04 |
| 285064 | OnabotulinumtoxinA | Muscle relaxants | 2024-05 | Issued Notice of Compliance | 2025-03 |
| 211762 | Osimertinib mesylate | Antineoplastic agents | 2018-01 | Issued Notice of Compliance | 2018-07 |
| 243288 | Osimertinib mesylate | Antineoplastic agents | 2020-09 | Issued Notice of Compliance | 2021-01 |
| 279138 | Osimertinib mesylate | Antineoplastic agents | 2023-10 | Issued Notice of Compliance | 2024-07 |
| 209413 | Outer membrane vesicles (Neisseria meningitidis group B NZ98/254 strain), recombinant Neisseria meningitidis group B NHBA fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B fHBP fusion protein | Vaccines | 2017-11 | Issued Notice of Compliance | 2018-08 |
| 248992 | Ozanimod | Immunosuppressants | 2021-05 | Issued Notice of Compliance | 2022-04 |
| 195948 | Palbociclib | Antineoplastic agents | 2016-07 | Issued Notice of Compliance | 2017-05 |
| 219500 | Palbociclib | Antineoplastic agents | 2018-10 | Issued Notice of Compliance | 2019-08 |
| 273901 | Palbociclib | Antineoplastic agents | 2023-05 | Issued Notice of Compliance | 2024-03 |
| 215829 | Palonosetron hydrochloride | Antiemetics and antinauseants | 2018-06 | Issued Notice of Compliance | 2019-04 |
| 193962 | Panitumumab | Antineoplastic agents | 2016-06 | Issued Notice of Compliance | 2017-04 |
| 209345 | Pasireotide | Pituitary and hypothalamic hormones and analogues | 2017-11 | Issued Notice of Compliance | 2018-08 |
| 201200 | Pembrolizumab | Antineoplastic agents | 2017-01 | Issued Notice of Compliance under the NOC/c Guidance | 2017-09 |
| 203157 | Pembrolizumab | Antineoplastic agents | 2017-03 | Issued Notice of Compliance | 2017-09 |
| 212388 | Pembrolizumab | Antineoplastic agents | 2018-01 | Issued Notice of Compliance under the NOC/c Guidance | 2018-09 |
| 215699 | Pembrolizumab | Antineoplastic agents | 2018-05 | Issued Notice of Compliance | 2019-03 |
| 216451 | Pembrolizumab | Antineoplastic agents | 2018-06 | Issued Notice of Compliance | 2019-04 |
| 218779 | Pembrolizumab | Antineoplastic agents | 2018-08 | Issued Notice of Compliance under the NOC/c Guidance | 2019-04 |
| 209011 | Pembrolizumab | Antineoplastic agents | 2017-09 | Issued Notice of Compliance | 2019-04 |
| 219700 | Pembrolizumab | Antineoplastic agents | 2018-10 | Issued Notice of Compliance | 2019-07 |
| 228721 | Pembrolizumab | Antineoplastic agents | 2019-07 | Issued Notice of Compliance under the NOC/c Guidance | 2019-09 |
| 223819 | Pembrolizumab | Antineoplastic agents | 2019-02 | Issued Notice of Compliance | 2019-12 |
| 219213 | Pembrolizumab | Antineoplastic agents | 2018-09 | Issued Notice of Compliance | 2020-03 |
| 232775 | Pembrolizumab | Antineoplastic agents | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 236910 | Pembrolizumab | Antineoplastic agents | 2020-04 | Issued Notice of Compliance under the NOC/c Guidance | 2020-12 |
| 239505 | Pembrolizumab | Antineoplastic agents | 2020-06 | Issued Notice of Compliance under the NOC/c Guidance | 2021-02 |
| 240864 | Pembrolizumab | Antineoplastic agents | 2020-07 | Issued Notice of Compliance | 2021-03 |
| 246922 | Pembrolizumab | Antineoplastic agents | 2020-12 | Issued Notice of Compliance | 2021-06 |
| 246373 | Pembrolizumab | Antineoplastic agents | 2020-12 | Issued Notice of Compliance under the NOC/c Guidance | 2021-11 |
| 252263 | Pembrolizumab | Antineoplastic agents | 2021-06 | Cancelled by sponsor | 2022-02 |
| 256659 | Pembrolizumab | Antineoplastic agents | 2021-10 | Issued Notice of Compliance | 2022-04 |
| 257236 | Pembrolizumab | Antineoplastic agents | 2021-11 | Issued Notice of Compliance | 2022-04 |
| 253060 | Pembrolizumab | Antineoplastic agents | 2021-07 | Issued Notice of Compliance | 2022-05 |
| 259703 | Pembrolizumab | Antineoplastic agents | 2022-01 | Issued Notice of Compliance | 2022-07 |
| 256537 | Pembrolizumab | Antineoplastic agents | 2021-10 | Issued Notice of Compliance | 2022-08 |
| 264318 | Pembrolizumab | Antineoplastic agents | 2022-06 | Issued Notice of Compliance | 2023-04 |
| 272409 | Pembrolizumab | Antineoplastic agents | 2023-03 | Issued Notice of Compliance | 2024-02 |
| 273487 | Pembrolizumab | Antineoplastic agents | 2023-05 | Issued Notice of Compliance | 2024-03 |
| 275053 | Pembrolizumab | Antineoplastic agents | 2023-06 | Issued Notice of Compliance | 2024-04 |
| 276501 | Pembrolizumab | Antineoplastic agents | 2023-08 | Issued Notice of Compliance | 2024-05 |
| 278399 | Pembrolizumab | Antineoplastic agents | 2023-10 | Issued Notice of Compliance | 2024-08 |
| 282981 | Pembrolizumab | Antineoplastic agents | 2024-02 | Issued Notice of Compliance | 2024-08 |
| 274453 | Pembrolizumab | Antineoplastic agents | 2023-06 | Issued Notice of Compliance | 2025-02 |
| 285469 | Pembrolizumab | Antineoplastic agents | 2024-05 | Issued Notice of Compliance | 2025-03 |
| 204327 | Perampanel | Antiepileptics | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 225719 | Perampanel | Antiepileptics | 2019-05 | Issued Notice of Compliance | 2020-02 |
| 209467 | Pertuzumab | Antineoplastic agents | 2017-11 | Issued Notice of Compliance | 2018-08 |
| 222022 | Pertuzumab, trastuzumab | Antineoplastic agents | 2018-12 | Issued Notice of Compliance | 2020-07 |
| 230602 | Pertuzumab, trastuzumab | Antineoplastic agents | 2019-09 | Issued Notice of Compliance | 2021-02 |
| 254251 | Pertuzumab, trastuzumab | Antineoplastic agents | 2021-07 | Issued Notice of Compliance | 2022-01 |
| 220947 | Pimecrolimus | Other dermatological preparations | 2018-11 | Issued Notice of Compliance | 2019-09 |
| 247851 | Pimecrolimus | Other dermatological preparations | 2021-01 | Cancelled by sponsor | 2023-09 |
| 270856 | Pitolisant hydrochloride | Other nervous system drugs | 2023-02 | Issued Notice of Compliance | 2024-01 |
| 284477 | Pitolisant hydrochloride | Other nervous system drugs | 2024-04 | Issued Notice of Compliance | 2025-02 |
| 279583 | Plecanatide | Drugs for constipation | 2024-01 | Issued Notice of Compliance | 2024-12 |
| 213345 | Plerixafor | Immunostimulants | 2018-02 | Issued Notice of Compliance | 2019-01 |
| 259726 | Polatuzumab vedotin | Antineoplastic agents | 2022-01 | Issued Notice of Compliance | 2022-11 |
| 218459 | Pomalidomide | Immunosuppressants | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 201272 | Ranibizumab | Ophthalmologicals | 2017-01 | Issued Notice of Compliance | 2017-11 |
| 233361 | Ranibizumab | Ophthalmologicals | 2019-11 | Issued Notice of Compliance under the NOC/c Guidance | 2021-11 |
| 259173 | Ravulizumab | Immunosuppressants | 2022-01 | Issued Notice of Compliance | 2022-11 |
| 261864 | Ravulizumab | Immunosuppressants | 2022-03 | Issued Notice of Compliance | 2023-01 |
| 269852 | Ravulizumab | Immunosuppressants | 2023-01 | Issued Notice of Compliance | 2023-10 |
| 223244 | Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | 2019-02 | Issued Notice of Compliance | 2020-08 |
| 251509 | Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | 2021-05 | Issued Notice of Compliance under the NOC/c Guidance | 2022-04 |
| 203322 | Regorafenib | Antineoplastic agents | 2017-04 | Issued Notice of Compliance | 2017-09 |
| 250151 | Remdesivir *For use in relation to COVID-19 | Antivirals for systemic use | 2021-04 | Issued Notice of Compliance | 2022-04 |
| 266313 | Remdesivir *For use in relation to COVID-19 | Antivirals for systemic use | 2022-08 | Issued Notice of Compliance | 2023-06 |
| 282013 | Respiratory syncytial virus prefusion F protein (RSVPreF3) | Vaccines | 2024-01 | Issued Notice of Compliance | 2024-11 |
| 225074 | Ribociclib succinate | Antineoplastic agents | 2019-04 | Issued Notice of Compliance | 2020-02 |
| 233623 | Ribociclib succinate | Antineoplastic agents | 2019-12 | Issued Notice of Compliance | 2020-10 |
| 262779 | Ribociclib succinate | Antineoplastic agents | 2022-04 | Issued Notice of Compliance | 2023-02 |
| 209230 | Rifaximin | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 2018-02 | Issued Notice of Compliance | 2018-12 |
| 251455 | Risankizumab | Immunosuppressants | 2021-05 | Issued Notice of Compliance | 2022-03 |
| 258394 | Risankizumab | Immunosuppressants | 2021-12 | Issued Notice of Compliance | 2022-10 |
| 280386 | Risankizumab | Immunosuppressants | 2023-12 | Issued Notice of Compliance | 2024-10 |
| 284770 | Risdiplam | Other drugs for disorders of the musculo-skeletal system | 2024-04 | Issued Notice of Compliance | 2024-10 |
| 204718 | Rituximab | Antineoplastic agents | 2017-05 | Issued Notice of Compliance | 2018-03 |
| 228130 | Rituximab | Antineoplastic agents | 2019-07 | Issued Notice of Compliance | 2020-05 |
| 242572 | Rituximab | Antineoplastic agents | 2020-09 | Issued Notice of Compliance | 2021-06 |
| 211611 | Rivaroxaban | Antithrombotic agents | 2018-01 | Issued Notice of Compliance | 2018-09 |
| 233166 | Rivaroxaban | Antithrombotic agents | 2020-02 | Issued Notice of Compliance | 2020-11 |
| 234756 | Rivaroxaban | Antithrombotic agents | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 280534 | Roflumilast | Antipsoriatics | 2023-12 | Issued Notice of Compliance | 2024-10 |
| 285437 | Roflumilast | Antipsoriatics | 2024-05 | Issued Notice of Compliance | 2025-03 |
| 243699 | Romiplostim | Antihemorrhagics | 2020-10 | Issued Notice of Compliance | 2021-08 |
| 262756 | Romosozumab | Drugs for treatment of bone diseases | 2022-05 | Cancelled by sponsor | 2023-03 |
| 194343 | Rufinamide | Antiepileptics | 2016-06 | Issued Notice of Compliance | 2017-04 |
| 250022 | Ruxolitinib phosphate | Antineoplastic agents | 2021-03 | Issued Notice of Compliance | 2022-05 |
| 270849 | Sacituzumab govitecan | Antineoplastic agents | 2023-01 | Issued Notice of Compliance | 2023-07 |
| 211993 | Sarilumab | Immunosuppressants | 2018-01 | Issued Notice of Compliance | 2019-08 |
| 266285 | SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 | Vaccines | 2022-07 | Issued Notice of Compliance | 2022-11 |
| 265342 | SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 | Vaccines | 2022-06 | Issued Notice of Compliance | 2022-12 |
| 273313 | SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 | Vaccines | 2023-03 | Cancelled by sponsor | 2023-11 |
| 219231 | Secukinumab | Immunosuppressants | 2018-09 | Issued Notice of Compliance | 2019-07 |
| 235994 | Secukinumab | Immunosuppressants | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 240496 | Secukinumab | Immunosuppressants | 2020-07 | Issued Notice of Compliance | 2021-05 |
| 250272 | Secukinumab | Immunosuppressants | 2021-05 | Issued Notice of Compliance | 2022-03 |
| 257230 | Secukinumab | Immunosuppressants | 2021-11 | Issued Notice of Compliance | 2022-09 |
| 269287 | Secukinumab | Immunosuppressants | 2022-12 | Issued Notice of Compliance | 2024-05 |
| 227387 | Semaglutide | Drugs used in diabetes | 2019-06 | Cancelled by sponsor | 2020-03 |
| 231580 | Semaglutide | Drugs used in diabetes | 2019-10 | Issued Notice of Compliance | 2020-08 |
| 245932 | Semaglutide | Drugs used in diabetes | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 266244 | Semaglutide | Drugs used in diabetes | 2022-09 | Issued Notice of Compliance | 2023-06 |
| 279915 | Semaglutide | Drugs used in diabetes | 2023-12 | Issued Notice of Compliance | 2024-11 |
| 211598 | Sevelamer carbonate | All other therapeutic products | 2018-04 | Issued Notice of Compliance | 2019-02 |
| 197253 | Simeprevir | Antivirals for systemic use | 2016-09 | Issued Notice of Compliance | 2017-07 |
| 199753 | Sofosbuvir, velpatasvir | Antivirals for systemic use | 2016-12 | Issued Notice of Compliance | 2017-09 |
| 233923 | Sofosbuvir, velpatasvir | Antivirals for systemic use | 2020-01 | Issued Notice of Compliance | 2020-11 |
| 205985 | Somatropin | Pituitary and hypothalamic hormones and analogues | 2017-06 | Issued Notice of Compliance | 2018-04 |
| 241147 | Somatropin | Pituitary and hypothalamic hormones and analogues | 2020-08 | Issued Notice of Compliance | 2021-06 |
| 229726 | Somatropin R-DNA origin | Pituitary and hypothalamic hormones and analogues | 2019-08 | Issued Notice of Compliance | 2020-06 |
| 278317 | Spesolimab | Immunosuppressants | 2023-10 | Issued Notice of Compliance | 2024-07 |
| 234565 | Standardized short ragweed pollen allergenic extract | Allergens | 2020-02 | Issued Notice of Compliance | 2020-12 |
| 234372 | Sugammadex | All other therapeutic products | 2020-01 | Issued Notice of Compliance | 2021-10 |
| 231944 | Sulfur hexafluoride | Contrast media | 2019-11 | Issued Notice of Compliance | 2020-08 |
| 208710 | Sunitinib malate | Antineoplastic agents | 2017-10 | Issued Notice of Non-compliance - Withdrawal | 2019-04 |
| 271537 | Talazoparib | Antineoplastic agents | 2023-05 | Issued Notice of Compliance | 2025-01 |
| 223862 | Teduglutide | Other alimentary tract and metabolism products | 2019-02 | Issued Notice of Compliance | 2019-08 |
| 231739 | Teriflunomide | Immunosuppressants | 2019-11 | Issued Notice of Compliance | 2020-09 |
| 199259 | Thioguanine | Antineoplastic agents | 2016-11 | Issued Notice of Compliance | 2017-09 |
| 231818 | Ticagrelor | Antithrombotic agents | 2019-10 | Issued Notice of Compliance | 2020-08 |
| 199839 | Tinzaparin sodium | Antithrombotic agents | 2016-12 | Cancelled by sponsor | 2018-11 |
| 227070 | Tipiracil hydrochloride, trifluridine | Antineoplastic agents | 2019-05 | Issued Notice of Compliance | 2019-11 |
| 263500 | Tisagenlecleucel | Antineoplastic agents | 2022-05 | Issued Notice of Compliance under the NOC/c Guidance | 2022-12 |
| 204251 | Tocilizumab | Immunosuppressants | 2017-05 | Issued Notice of Compliance | 2017-10 |
| 219690 | Tocilizumab | Immunosuppressants | 2018-10 | Issued Notice of Compliance | 2019-07 |
| 220039 | Tocilizumab | Immunosuppressants | 2018-10 | Issued Notice of Compliance | 2019-08 |
| 261220 | Tocilizumab *For use in relation to COVID-19 | Immunosuppressants | 2022-02 | Issued Notice of Compliance | 2022-10 |
| 209522 | Tofacitinib | Immunosuppressants | 2017-11 | Issued Notice of Compliance | 2018-09 |
| 209643 | Tofacitinib | Immunosuppressants | 2017-12 | Issued Notice of Compliance | 2018-10 |
| 213578 | Tofacitinib | Immunosuppressants | 2018-04 | Issued Notice of Compliance | 2019-01 |
| 264582 | Tofacitinib citrate | Immunosuppressants | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 271059 | Tofacitinib citrate | Immunosuppressants | 2023-03 | Issued Notice of Compliance | 2024-04 |
| 213262 | Tolvaptan | Diuretics | 2018-03 | Issued Notice of Compliance | 2019-01 |
| 251730 | Tozinameran *For use in relation to COVID-19 | Vaccines | 2021-04 | Authorized under Interim Order | 2021-05 |
| 257162 | Tozinameran *For use in relation to COVID-19 | Vaccines | 2021-10 | Issued Notice of Compliance | 2021-11 |
| 257698 | Tozinameran *For use in relation to COVID-19 | Vaccines | 2021-10 | Issued Notice of Compliance | 2021-11 |
| 261729 | Tozinameran *For use in relation to COVID-19 | Vaccines | 2022-02 | Issued Notice of Compliance | 2022-06 |
| 264621 | Tozinameran *For use in relation to COVID-19 | Vaccines | 2022-05 | Issued Notice of Compliance | 2022-08 |
| 265483 | Tozinameran *For use in relation to COVID-19 | Vaccines | 2022-06 | Issued Notice of Compliance | 2022-09 |
| 261661 | Tralokinumab | Other dermatological preparations | 2022-04 | Issued Notice of Compliance | 2023-02 |
| 199382 | Trametinib | Antineoplastic agents | 2016-11 | Issued Notice of Compliance | 2017-05 |
| 210760 | Trametinib | Antineoplastic agents | 2017-11 | Issued Notice of Compliance | 2018-05 |
| 213580 | Trametinib | Antineoplastic agents | 2018-03 | Issued Notice of Compliance | 2018-09 |
| 270386 | Trametinib | Antineoplastic agents | 2023-01 | Issued Notice of Compliance | 2023-07 |
| 226272 | Trastuzumab | Antineoplastic agents | 2019-04 | Issued Notice of Compliance | 2019-08 |
| 239083 | Trastuzumab | Antineoplastic agents | 2020-06 | Issued Notice of Compliance | 2021-04 |
| 237674 | Trastuzumab | Antineoplastic agents | 2020-05 | Issued Notice of Compliance | 2021-04 |
| 242479 | Trastuzumab | Antineoplastic agents | 2020-09 | Issued Notice of Compliance | 2021-04 |
| 247842 | Trastuzumab | Antineoplastic agents | 2021-02 | Issued Notice of Compliance | 2021-12 |
| 259440 | Trastuzumab deruxtecan | Antineoplastic agents | 2022-01 | Issued Notice of Compliance | 2022-06 |
| 265333 | Trastuzumab deruxtecan | Antineoplastic agents | 2022-07 | Issued Notice of Compliance | 2023-01 |
| 285834 | Trastuzumab deruxtecan | Antineoplastic agents | 2024-05 | Issued Notice of Compliance | 2025-01 |
| 227372 | Trastuzumab emtansine | Antineoplastic agents | 2019-05 | Issued Notice of Compliance | 2019-11 |
| 235656 | Tretinoin | Anti-acne preparations | 2020-03 | Issued Notice of Compliance | 2021-01 |
| 222505 | Umeclidinium bromide | Drugs for obstructive airway diseases | 2019-01 | Issued Notice of Compliance | 2020-09 |
| 241253 | Upadacitinib | Immunosuppressants | 2020-08 | Issued Notice of Compliance | 2021-06 |
| 245530 | Upadacitinib | Immunosuppressants | 2020-12 | Issued Notice of Compliance | 2021-10 |
| 247702 | Upadacitinib | Immunosuppressants | 2021-02 | Issued Notice of Compliance | 2022-07 |
| 264612 | Upadacitinib | Immunosuppressants | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 257284 | Upadacitinib | Immunosuppressants | 2021-12 | Issued Notice of Compliance | 2023-07 |
| 267554 | Upadacitinib | Immunosuppressants | 2022-12 | Issued Notice of Compliance | 2023-10 |
| 224739 | Ustekinumab | Immunosuppressants | 2019-03 | Issued Notice of Compliance | 2020-01 |
| 230279 | Ustekinumab | Immunosuppressants | 2019-08 | Issued Notice of Compliance | 2020-06 |
| 285419 | Ustekinumab | Immunosuppressants | 2024-05 | Issued Notice of Compliance | 2024-11 |
| 289290 | Ustekinumab | Immunosuppressants | 2024-09 | Issued Notice of Compliance | 2025-02 |
| 246933 | Varicella-zoster virus glycoprotein E (GE) | Vaccines | 2021-01 | Issued Notice of Compliance | 2021-11 |
| 214078 | Venetoclax | Antineoplastic agents | 2018-03 | Issued Notice of Compliance | 2018-09 |
| 228475 | Venetoclax | Antineoplastic agents | 2019-07 | Issued Notice of Compliance | 2020-04 |
| 240541 | Venetoclax | Antineoplastic agents | 2020-06 | Issued Notice of Compliance | 2020-12 |
| 210066 | Vilazodone hydrochloride | Psychoanaleptics | 2017-11 | Cancelled by sponsor | 2018-10 |
| 267448 | Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 | Vaccines | 2022-08 | Issued Notice of Compliance | 2023-03 |
| 254556 | Zanubrutinib | Antineoplastic agents | 2021-09 | Issued Notice of Compliance | 2022-02 |
| 264963 | Zanubrutinib | Antineoplastic agents | 2022-07 | Issued Notice of Compliance | 2023-05 |
| 273215 | Zanubrutinib | Antineoplastic agents | 2023-04 | Issued Notice of Compliance | 2024-02 |
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