| 5-Aminolevulinic acid |
Antineoplastic agents |
234673 |
2020-03 |
2020-09 |
Issued Notice of Compliance |
| Abaloparatide |
Calcium homeostasis |
259301 |
2022-03 |
2023-01 |
Cancelled by sponsor |
| Abemaciclib |
Antineoplastic agents |
215268 |
2018-06 |
2019-04 |
Issued Notice of Compliance |
| Abrocitinib |
Other dermatological preparations |
245854 |
2020-12 |
2022-06 |
Issued Notice of Compliance |
| Acalabrutinib |
Antineoplastic agents |
214504 |
2018-04 |
2019-08 |
Issued Notice of Compliance |
| Acalabrutinib |
Antineoplastic agents |
259246 |
2022-05 |
2023-02 |
Issued Notice of Compliance |
| Acetaminophen |
Analgesics |
209478 |
2018-02 |
2018-11 |
Issued Notice of Compliance |
| Acetaminophen |
Analgesics |
244695 |
2021-04 |
2023-02 |
Issued Notice of Compliance |
| Acetylsalicylic acid, atorvastatin calcium, ramipril |
Cardiac therapy |
234460 |
2020-02 |
2021-03 |
Cancelled by sponsor |
| Ad26.COV2.S (recombinant) |
Vaccines |
253702 |
2021-07 |
2021-11 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
203250 |
2017-04 |
2018-05 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
203292 |
2017-04 |
2018-05 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
230637 |
2019-10 |
2020-10 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
217314 |
2018-11 |
2020-11 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
229124 |
2019-09 |
2020-11 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
235685 |
2020-03 |
2021-01 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
247265 |
2021-03 |
2021-12 |
Issued Notice of Compliance |
| Adalimumab |
Immunosuppressants |
244990 |
2021-02 |
2022-01 |
Issued Notice of Compliance |
| Aducanumab |
Other nervous system drugs |
251005 |
2021-06 |
2022-05 |
Cancelled by sponsor |
| Alectinib |
Antineoplastic agents |
189442 |
2016-02 |
2016-09 |
Issued Notice of Compliance under the NOC/c Guidance |
| Alfa 1-proteinase inhibitor (human) |
Antihemorrhagics |
246730 |
2021-01 |
2021-11 |
Issued Notice of Compliance |
| Alirocumab |
Lipid modifying agents |
183116 |
2015-06 |
2016-04 |
Issued Notice of Compliance |
| Alpelisib |
Antineoplastic agents |
226941 |
2019-05 |
2020-03 |
Issued Notice of Compliance |
| Alvimopan |
Drugs for constipation |
189825 |
2016-03 |
2017-03 |
Cancelled by sponsor |
| Amifampridine |
Other nervous system drugs |
234655 |
2020-02 |
2021-06 |
Notice of Compliance invalid |
| Amifampridine phosphate |
Other nervous system drugs |
232685 |
2020-02 |
2020-07 |
Issued Notice of Compliance |
| Amisulpride |
Psycholeptics |
235705 |
2020-03 |
2021-02 |
Cancelled by sponsor |
| Amivantamab |
Antineoplastic agents |
254440 |
2021-07 |
2022-03 |
Issued Notice of Compliance under the NOC/c Guidance |
| Amlodipine besylate |
Calcium channel blockers |
211854 |
2018-07 |
2019-01 |
Issued Notice of Compliance |
| Amoxicillin sodium, clavulanic acid |
Antibacterials for systemic use |
221964 |
2019-04 |
2020-01 |
Issued Notice of Compliance |
| Anifrolumab |
Immunosuppressants |
246187 |
2020-12 |
2021-11 |
Issued Notice of Compliance |
| Anthrax antigen filtrate |
Vaccines |
212387 |
2018-02 |
2018-12 |
Issued Notice of Compliance |
| Anthrax immunoglobulin (human) |
Immune sera and immunoglobulins |
200446 |
2017-01 |
2017-11 |
Issued Notice of Compliance |
| Antihemophilic factor (human), Von Willebrand factor (human) |
Antihemorrhagics |
194071 |
2017-06 |
2018-05 |
Issued Notice of Compliance |
| Antihemophilic factor (recombinant), pegylated |
Antihemorrhagics |
189709 |
2016-01 |
2016-11 |
Issued Notice of Compliance |
| Antihemophilic factor (recombinant, B-domain deleted, pegylated) |
Antihemorrhagics |
210935 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
| Antihemophilic factor VIII (Recombinant, B-domain truncated), pegylated |
Antihemorrhagics |
218531 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
| Apalutamide |
Endocrine therapy |
211942 |
2018-01 |
2018-07 |
Issued Notice of Compliance |
| Apomorphine hydrochloride |
Anti-parkinson drugs |
217320 |
2018-08 |
2020-06 |
Issued Notice of Compliance |
| Aprotinin |
Antihemorrhagics |
247924 |
2021-02 |
2022-02 |
Cancelled by sponsor |
| Asciminib hydrochloride |
Antineoplastic agents |
255700 |
2021-08 |
2022-06 |
Issued Notice of Compliance |
| Ataluren |
Other drugs for disorders of the musculo-skeletal system |
186992 |
2015-09 |
2016-03 |
Cancelled by sponsor |
| Ataluren |
Other drugs for disorders of the musculo-skeletal system |
217349 |
2018-09 |
2019-10 |
Cancelled by sponsor |
| Atezolizumab |
Antineoplastic agents |
196843 |
2016-08 |
2017-04 |
Issued Notice of Compliance under the NOC/c Guidance |
| Atogepant |
Analgesics |
253186 |
2021-07 |
2022-12 |
Issued Notice of Compliance |
| Avacopan |
Immunosuppressants |
248255 |
2021-05 |
2022-04 |
Issued Notice of Compliance |
| Avalglucosidase alfa |
Other alimentary tract and metabolism |
245680 |
2020-11 |
2021-11 |
Issued Notice of Compliance |
| Avanafil |
Urologicals |
220887 |
2019-06 |
2021-10 |
Issued Notice of Non-compliance - Withdrawal |
| Avelumab |
Antineoplastic agents |
204052 |
2017-04 |
2017-12 |
Issued Notice of Compliance under the NOC/c Guidance |
| Avelumab |
Antineoplastic agents |
208742 |
2017-09 |
2018-05 |
Issued Notice of Compliance under the NOC/c Guidance |
| Axicabtagene ciloleucel |
Antineoplastic agents |
218389 |
2018-08 |
2019-02 |
Issued Notice of Compliance |
| Azacitidine |
Antineoplastic agents |
240668 |
2020-07 |
2021-01 |
Issued Notice of Compliance |
| Bacillus Calmette-Guerin BCG – Strain Russian BCG-I |
Immunostimulants |
221579 |
2018-12 |
2020-12 |
Issued Notice of Compliance under the NOC/c Guidance |
| Baloxavir marboxil |
Antivirals for systemic use |
227361 |
2019-05 |
2020-02 |
Issued Notice of Compliance |
| Bamlanivimab |
Immune sera and immunoglobulins |
253646 |
2021-07 |
2023-02 |
Cancelled by sponsor |
| Baricitinib |
Antiinflammatory and antirheumatic products |
193687 |
2016-05 |
2018-08 |
Issued Notice of Compliance |
| Belinostat |
Antineoplastic agents |
208886 |
2017-12 |
2019-11 |
Cancelled by sponsor |
| Belumosudil mesylate |
Immunosuppressants |
245791 |
2021-01 |
2022-03 |
Issued Notice of Compliance |
| Belzutifan |
Antineoplastic agents |
254495 |
2021-09 |
2022-07 |
Issued Notice of Compliance |
| Bendamustine hydrochloride |
Antineoplastic agents |
248962 |
2021-03 |
2022-01 |
Issued Notice of Compliance |
| Bendamustine hydrochloride |
Antineoplastic agents |
249957 |
2021-07 |
2022-05 |
Issued Notice of Compliance |
| Benralizumab |
Immunosuppressants |
204008 |
2017-04 |
2018-02 |
Issued Notice of Compliance |
| Bepotastine besilate |
Ophthalmologicals |
179294 |
2015-10 |
2016-07 |
Issued Notice of Compliance |
| Berotralstat hydrochloride |
Other hematological agents |
252301 |
2021-08 |
2022-06 |
Issued Notice of Compliance |
| Betamethasone valerate, fusidic acid |
Corticosteroids, dermatological preparations |
203765 |
2017-06 |
2018-04 |
Issued Notice of Compliance |
| Betula verrucosa extract |
Nasal preparations |
227270 |
2019-06 |
2020-04 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
201427 |
2017-02 |
2018-04 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
218183 |
2018-08 |
2019-06 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
217524 |
2018-08 |
2021-01 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
242395 |
2020-10 |
2021-09 |
Cancelled by sponsor |
| Bevacizumab |
Antineoplastic agents |
244450 |
2020-11 |
2021-09 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
237499 |
2020-07 |
2021-11 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
247369 |
2021-02 |
2021-11 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
247724 |
2021-02 |
2021-11 |
Issued Notice of Compliance |
| Bevacizumab |
Antineoplastic agents |
258973 |
2022-03 |
2023-01 |
Issued Notice of Compliance |
| Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
203718 |
2017-09 |
2018-07 |
Issued Notice of Compliance |
| Bilastine |
Antihistamines for systemic use |
184231 |
2015-06 |
2016-04 |
Issued Notice of Compliance |
| Bimatoprost |
Ophthalmologicals |
259843 |
2022-02 |
2022-12 |
Issued Notice of Compliance |
| Bimekizumab |
Immunosuppressants |
238499 |
2021-04 |
2022-02 |
Issued Notice of Compliance |
| Binimetinib |
Antineoplastic agents |
237410 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
| Bisoprolol fumarate |
Beta blocking agents |
203050 |
2017-07 |
2019-11 |
Issued Notice of Compliance |
| Bisoprolol fumarate |
Beta blocking agents |
231842 |
2020-05 |
2020-09 |
Cancelled by sponsor |
| Bivalirudin |
Antithrombotic agents |
232423 |
2019-11 |
2020-09 |
Issued Notice of Compliance |
| Blinatumomab |
Antineoplastic agents |
181723 |
2015-04 |
2015-12 |
Issued Notice of Compliance under the NOC/c Guidance |
| Botulinum antitoxin, serotypes A, B, C, D, E, F, G |
Immune sera and immunoglobulins |
190645 |
2016-02 |
2016-12 |
Issued Notice of Compliance |
| Brexpiprazole |
Psycholeptics |
192684 |
2016-04 |
2017-02 |
Issued Notice of Compliance |
| Brexucabtagene autoleucel |
Antineoplastic agents |
246355 |
2020-12 |
2021-06 |
Issued Notice of Compliance |
| Brigatinib |
Antineoplastic agents |
210369 |
2017-11 |
2018-07 |
Issued Notice of Compliance under the NOC/c Guidance |
| Brilliant blue G |
Ophthalmologicals |
232449 |
2020-03 |
2021-01 |
Issued Notice of Compliance |
| Brivaracetam |
Antiepileptics |
183355 |
2015-05 |
2016-03 |
Issued Notice of Compliance |
| Brodalumab |
Immunosuppressants |
195317 |
2016-07 |
2018-03 |
Issued Notice of Compliance |
| Brolucizumab |
Ophthalmologicals |
226224 |
2019-05 |
2020-03 |
Issued Notice of Compliance |
| Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
227232 |
2019-05 |
2019-11 |
Issued Notice of Compliance |
| Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
220876 |
2019-06 |
2020-04 |
Issued Notice of Compliance |
| Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide |
Drugs for obstructive airway diseases |
242357 |
2020-09 |
2021-07 |
Issued Notice of Compliance |
| Bupivacaine |
Anesthetics |
231224 |
2019-12 |
2021-08 |
Cancelled by sponsor |
| Bupivacaine, meloxicam |
Antiinflammatory and antirheumatic products |
233561 |
2020-01 |
2022-03 |
Issued Notice of Compliance |
| Buprenorphine |
Other nervous system drugs |
215660 |
2018-05 |
2018-11 |
Issued Notice of Compliance |
| Buprenorphine hydrochloride |
Other nervous system drugs |
196428 |
2016-08 |
2017-06 |
Issued Notice of Compliance |
| Buprenorphine hydrochloride |
Other nervous system drugs |
204746 |
2017-06 |
2018-04 |
Issued Notice of Compliance |
| Bupropion hydrochloride, naltrexone hydrochloride |
Antiobesity preparations, excluding diet products |
202774 |
2017-04 |
2018-02 |
Issued Notice of Compliance |
| Burosumab |
Drugs for treatment of bone diseases |
216239 |
2018-06 |
2018-12 |
Issued Notice of Compliance |
| C1 esterase inhibitor (human) |
Other hematological agents |
198308 |
2016-11 |
2017-09 |
Issued Notice of Compliance |
| Cabotegravir, rilpivirine |
Antivirals for systemic use |
227315 |
2019-05 |
2020-03 |
Issued Notice of Compliance |
| Cabozantinib |
Antineoplastic agents |
206230 |
2017-07 |
2018-09 |
Issued Notice of Compliance |
| Caffeine citrate |
Psychoanaleptics |
225810 |
2019-05 |
2020-03 |
Issued Notice of Compliance |
| Calcifediol |
Vitamins |
205392 |
2017-09 |
2018-07 |
Issued Notice of Compliance |
| Canakinumab |
Immunosuppressants |
213303 |
2018-06 |
2018-12 |
Cancelled by sponsor |
| Cangrelor tetrasodium |
Antithrombotic agents |
255032 |
2021-11 |
2023-01 |
Issued Notice of Compliance |
| Caplacizumab |
Antithrombotic agents |
230001 |
2019-08 |
2020-02 |
Issued Notice of Compliance |
| Capmatinib dihydrochloride |
Antineoplastic agents |
255972 |
2021-09 |
2022-05 |
Issued Notice of Compliance under the NOC/c Guidance |
| Carbidopa, levodopa |
Anti-parkinson drugs |
257242 |
2022-04 |
2022-10 |
Issued Notice of Compliance |
| Carfilzomib |
Antineoplastic agents |
184479 |
2015-07 |
2016-01 |
Issued Notice of Compliance |
| Cariprazine hydrochloride |
Psycholeptics |
249774 |
2021-06 |
2022-04 |
Issued Notice of Compliance |
| Cedazuridine, decitabine |
Antineoplastic agents |
234610 |
2020-01 |
2020-07 |
Issued Notice of Compliance |
| Cefixime |
Antibacterials for systemic use |
189720 |
2016-05 |
2017-10 |
Issued Notice of Compliance |
| Cemiplimab |
Antineoplastic agents |
218718 |
2018-08 |
2019-04 |
Issued Notice of Compliance under the NOC/c Guidance |
| Cenegermin |
Ophthalmologicals |
218145 |
2018-08 |
2019-02 |
Issued Notice of Compliance |
| Cerliponase alfa |
Other alimentary tract and metabolism products |
216539 |
2018-06 |
2018-12 |
Issued Notice of Compliance |
| Cevimeline hydrochloride |
Other nervous system drugs |
240337 |
2020-09 |
2022-04 |
Issued Notice of Non-compliance - Withdrawal |
| ChAdOx1-S (recombinant) |
Vaccines |
253700 |
2021-07 |
2021-11 |
Issued Notice of Compliance |
| Chlormethine |
Antineoplastic agents |
238994 |
2020-08 |
2021-06 |
Issued Notice of Compliance |
| Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride |
Blood substitutes and perfusion solutions |
223801 |
2019-06 |
2020-04 |
Issued Notice of Compliance |
| Cidofovir |
Antivirals for systemic use |
200865 |
2017-04 |
2018-03 |
Issued Notice of Compliance |
| Cilgavimab, tixagevimab |
Immune sera and immunoglobulins |
258295 |
2021-11 |
2022-04 |
Issued Notice of Compliance |
| Cilostazol |
Antithrombotic agents |
240368 |
2021-02 |
2022-07 |
Cancelled by sponsor |
| Ciltacabtagene autoleucel |
Antineoplastic agents |
262122 |
2022-04 |
2023-02 |
Issued Notice of Compliance under the NOC/c Guidance |
| Cinnarizine, dimenhydrinate |
Other nervous system drugs |
195151 |
2016-09 |
2018-11 |
Issued Notice of Non-compliance - Withdrawal |
| Cladribine |
Immunosuppressants |
200943 |
2017-02 |
2017-11 |
Issued Notice of Compliance |
| Clozapine |
Psycholeptics |
193638 |
2016-05 |
2016-11 |
Issued Notice of Compliance |
| Coagulation factor IX (recombinant), pegylated |
Antihemorrhagics |
201114 |
2017-02 |
2017-11 |
Issued Notice of Compliance |
| Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
199705 |
2017-05 |
2018-03 |
Issued Notice of Compliance |
| Cobimetinib fumarate |
Antineoplastic agents |
182788 |
2015-04 |
2016-02 |
Issued Notice of Compliance |
| Colchicine |
Antigout preparations |
248423 |
2021-02 |
2021-08 |
Issued Notice of Compliance |
| Concizumab |
Antihemorrhagics |
267120 |
2022-09 |
2023-03 |
Issued Notice of Compliance |
| Copanlisib dihydrochloride |
Antineoplastic agents |
255077 |
2021-08 |
2021-12 |
Cancelled by sponsor |
| 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 |
253111 |
2021-07 |
2022-05 |
Issued Notice of Compliance |
| 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 |
247042 |
2021-01 |
2021-11 |
Issued Notice of Compliance |
| Crisaborole |
Other dermatological preparations |
206906 |
2017-08 |
2018-06 |
Issued Notice of Compliance |
| Crisantaspase, recombinant |
Antineoplastic drugs |
257092 |
2021-11 |
2022-09 |
Issued Notice of Compliance |
| Cyclosporine |
Ophthalmologicals |
194580 |
2016-08 |
2018-04 |
Issued Notice of Non-compliance - Withdrawal |
| Cyclosporine |
Ophthalmologicals |
215813 |
2018-07 |
2018-12 |
Issued Notice of Compliance |
| Cyclosporine |
Ophthalmologicals |
234677 |
2020-04 |
2021-02 |
Issued Notice of Compliance |
| Cysteamine hydrochloride |
Ophthalmologicals |
211635 |
2018-02 |
2019-02 |
Issued Notice of Compliance |
| Cytarabine, daunorubicin hydrochloride |
Antineoplastic agents |
242743 |
2020-11 |
2021-04 |
Issued Notice of Compliance |
| Daclizumab |
Immunosuppressants |
190458 |
2016-02 |
2016-12 |
Issued Notice of Compliance |
| Dacomitinib |
Antineoplastic agents |
214572 |
2018-05 |
2019-02 |
Issued Notice of Compliance |
| Dalbavancin |
Antibacterials for systemic use |
212390 |
2018-03 |
2018-09 |
Issued Notice of Compliance |
| Daratumumab |
Antineoplastic agents |
187648 |
2015-11 |
2016-06 |
Issued Notice of Compliance under the NOC/c Guidance |
| Darolutamide |
Endocrine therapy |
226146 |
2019-04 |
2020-02 |
Issued Notice of Compliance |
| Darvadstrocel |
Unassigned |
217347 |
2018-08 |
2019-06 |
Cancelled by sponsor |
| Davesomeran, elasomeran |
Vaccines |
267589 |
2022-09 |
2022-11 |
Issued Notice of Compliance |
| Decitabine |
Antineoplastic agents |
207372 |
2018-03 |
2019-01 |
Issued Notice of Compliance |
| Decitabine |
Antineoplastic agents |
217663 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
| Defibrotide |
Antithrombotic agents |
200808 |
2017-01 |
2017-07 |
Issued Notice of Compliance |
| Dequalinium chloride |
Gynecological antiinfectives and antiseptics |
227886 |
2019-07 |
2021-07 |
Issued Notice of Compliance |
| Dermatophagoides farinae, dermatophagoides pteronyssinus |
Allergens |
208152 |
2017-09 |
2020-07 |
Cancelled by sponsor |
| Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract |
Allergens |
195186 |
2016-07 |
2017-05 |
Issued Notice of Compliance |
| Desvenlafaxine |
Psychoanaleptics |
199626 |
2017-02 |
2017-08 |
Issued Notice of Compliance |
| Deucravacitinib |
Immunosuppressants |
259397 |
2022-01 |
2022-11 |
Issued Notice of Compliance |
| Dexamethasone sodium phosphate, netilmicin sulfate |
Ophthalmologicals |
212391 |
2018-02 |
2019-10 |
Issued Notice of Compliance |
| Diamorphine hydrochloride |
Other nervous system drugs |
254850 |
2021-08 |
2022-02 |
Issued Notice of Compliance |
| Difelikefalin |
All other therapeutic products |
254548 |
2021-10 |
2022-08 |
Issued Notice of Compliance |
| Dinutuximab |
Antineoplastic agents |
212066 |
2018-02 |
2018-11 |
Issued Notice of Compliance |
| Diroximel fumarate |
Immunosuppressants |
240071 |
2020-07 |
2023-02 |
Cancelled by sponsor |
| Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, sodium phosphate monobasic |
All other non-therapeutic products |
220402 |
2018-11 |
2019-09 |
Issued Notice of Compliance |
| Dolutegravir, lamivudine |
Antivirals for systemic use |
220275 |
2018-10 |
2019-08 |
Issued Notice of Compliance |
| Dolutegravir sodium, rilpivirine hydrochloride |
Antivirals for systemic use |
206402 |
2017-07 |
2018-05 |
Issued Notice of Compliance |
| Doravirine |
Antivirals for systemic use |
211293 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
| Doravirine, lamivudine, tenofovir disoproxil fumarate |
Antivirals for systemic use |
211708 |
2018-01 |
2018-11 |
Issued Notice of Compliance |
| Dostarlimab |
Antineoplastic agents |
251105 |
2021-04 |
2021-12 |
Issued Notice of Compliance under the NOC/c Guidance |
| Dotatate |
Diagnostic radiopharmaceuticals |
218346 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
| Drospirenone |
Sex hormones and modulators of the genital system |
242176 |
2021-02 |
2021-11 |
Issued Notice of Compliance |
| Drospirenone, estetrol monohydrate |
Sex hormones and modulators of the genital system |
236197 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
| Dupilumab |
Immunosuppressants |
201285 |
2017-02 |
2017-11 |
Issued Notice of Compliance |
| Durvalumab |
Antineoplastic agents |
202953 |
2017-03 |
2017-11 |
Issued Notice of Compliance under the NOC/c Guidance |
| Durvalumab |
Antineoplastic agents |
208834 |
2017-09 |
2018-05 |
Issued Notice of Compliance under the NOC/c Guidance |
| Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live, attenuated) |
Vaccines |
256568 |
2021-10 |
2022-11 |
Issued Notice of Compliance |
| Edaravone |
Other nervous system drugs |
214391 |
2018-04 |
2018-10 |
Issued Notice of Compliance |
| Edoxaban |
Antithrombotic agents |
187363 |
2015-12 |
2016-11 |
Issued Notice of Compliance |
| Elagolix |
Sex hormones and modulators of the genital system |
209513 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
| Elasomeran |
Vaccines |
252733 |
2021-06 |
2021-09 |
Issued Notice of Compliance |
| Elasomeran, imelasomeran |
Vaccines |
265656 |
2022-06 |
2022-09 |
Issued Notice of Compliance |
| Elbasvir, grazoprevir |
Antivirals for systemic use |
185866 |
2015-07 |
2016-01 |
Issued Notice of Compliance |
| Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
246955 |
2020-12 |
2021-06 |
Issued Notice of Compliance |
| Eliglustat tartrate |
Other alimentary tract and metabolism products |
183050 |
2015-05 |
2017-04 |
Issued Notice of Compliance |
| Elotuzumab |
Antineoplastic agents |
188144 |
2015-12 |
2016-06 |
Issued Notice of Compliance |
| Eluxadoline |
Drugs for functional gastrointestinal disorders |
190162 |
2016-04 |
2017-01 |
Issued Notice of Compliance |
| Emapalumab |
Immunosuppressants |
237121 |
2020-05 |
2021-02 |
Cancelled by sponsor |
| Emicizumab |
Antihemorrhagics |
212635 |
2018-02 |
2018-08 |
Issued Notice of Compliance |
| Enasidenib mesylate |
Antineoplastic agents |
217033 |
2018-07 |
2019-02 |
Issued Notice of Compliance under the NOC/c Guidance |
| Encorafenib |
Antineoplastic agents |
237413 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
| Encorafenib |
Antineoplastic agents |
238571 |
2020-06 |
2021-03 |
Issued Notice of Compliance |
| Enfortumab vedotin |
Antineoplastic agents |
251438 |
2021-05 |
2021-10 |
Issued Notice of Compliance |
| Enoxaparin sodium |
Antithrombotic agents |
233058 |
2019-12 |
2020-10 |
Issued Notice of Compliance |
| Enoxaparin sodium |
Antithrombotic agents |
233987 |
2020-01 |
2020-11 |
Issued Notice of Compliance |
| Enoxaparin sodium |
Antithrombotic agents |
231767 |
2019-11 |
2020-12 |
Issued Notice of Compliance |
| Enoxaparin sodium |
Antithrombotic agents |
243026 |
2021-12 |
2022-10 |
Issued Notice of Compliance |
| Entrectinib |
Antineoplastic agents |
227517 |
2019-06 |
2020-02 |
Issued Notice of Compliance under the NOC/c Guidance |
| Entrectinib |
Antineoplastic agents |
228159 |
2019-07 |
2020-05 |
Issued Notice of Compliance |
| Eptinezumab |
Analgesics |
233288 |
2020-03 |
2021-01 |
Issued Notice of Compliance |
| Erdafitinib |
Antineoplastic agents |
224529 |
2019-03 |
2019-10 |
Issued Notice of Compliance under the NOC/c Guidance |
| Erenumab |
Analgesics |
208607 |
2017-10 |
2018-08 |
Issued Notice of Compliance |
| Ertugliflozin pidolate |
Drugs used in diabetes |
204724 |
2017-07 |
2018-05 |
Issued Notice of Compliance |
| Ertugliflozin pidolate, metformin hydrochloride |
Drugs used in diabetes |
201005 |
2017-08 |
2018-05 |
Issued Notice of Compliance |
| Ertugliflozin pidolate, sitagliptin phosphate monohydrate |
Drugs used in diabetes |
201006 |
2017-07 |
2018-05 |
Issued Notice of Compliance |
| Esketamine hydrochloride |
Psychoanaleptics |
222855 |
2019-01 |
2020-05 |
Issued Notice of Compliance |
| Estradiol hemihydrate |
Sex hormones and modulators of the genital system |
223938 |
2019-10 |
2020-08 |
Issued Notice of Compliance |
| Estradiol hemihydrate, progesterone |
Sex hormones and modulators of the genital system |
224010 |
2019-11 |
2020-09 |
Issued Notice of Compliance |
| Estriol, lactobacillus acidophilus |
Sex hormones and modulators of the genital system |
203472 |
2017-06 |
2019-01 |
Issued a Notice of Deficiency - Withdrawal |
| Etanercept |
Immunosuppressants |
193864 |
2016-06 |
2017-04 |
Issued Notice of Compliance |
| Etanercept |
Immunosuppressants |
234562 |
2020-02 |
2022-08 |
Issued Notice of Compliance |
| Etesevimab |
Immune sera and immunoglobulins |
256653 |
2021-09 |
2023-02 |
Cancelled by sponsor
|
| Etomidate |
Anesthetics |
231245 |
2019-12 |
2020-07 |
Issued Notice of Compliance |
| Etonogestrel |
Sex hormones and modulators of the genital system |
226314 |
2019-05 |
2020-05 |
Issued Notice of Compliance |
| Famtozinameran, tozinameran |
Vaccines |
267502 |
2022-09 |
2022-10 |
Issued Notice of Compliance |
| Faricimab |
Ophthalmologicals |
253904 |
2021-08 |
2022-05 |
Issued Notice of Compliance |
| Favipiravir |
Antivirals for systemic use |
256417 |
2020-12 |
2022-02 |
Cancelled by sponsor |
| Fedratinib dihydrochloride monohydrate |
Antineoplastic agents |
229866 |
2019-10 |
2020-07 |
Issued Notice of Compliance |
| Ferric pyrophosphate citrate |
Antianemic preparations |
239850 |
2020-06 |
2021-04 |
Issued Notice of Compliance |
| Ferumoxytol |
Antianemic preparations |
258248 |
2022-03 |
2023-02 |
Cancelled by sponsor |
| Fibrinogen (human) |
Antihemorrhagics |
195870 |
2016-08 |
2017-06 |
Issued Notice of Compliance |
| Fibrinogen (human), thrombin (human) |
Antihemorrhagics |
239016 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
| Filgotinib |
Immunosuppressants |
235219 |
2020-04 |
2021-01 |
Cancelled by sponsor |
| Filgrastim (r-metHuG-CSF) |
Immunostimulants |
212016 |
2018-02 |
2019-08 |
Cancelled by sponsor |
| Filgrastim (r-metHuG-CSF) |
Immunostimulants |
214080 |
2018-04 |
2020-04 |
Issued Notice of Compliance |
| Filgrastim (r-metHuG-CSF) |
Immunostimulants |
220512 |
2019-03 |
2021-10 |
Issued Notice of Compliance |
| Finerenone |
Diuretics |
249486 |
2021-04 |
2021-10 |
Cancelled by sponsor |
| Finerenone |
Diuretics |
258231 |
2021-12 |
2022-10 |
Issued Notice of Compliance |
| Flibanserin |
Other gynecologicals |
189352 |
2016-04 |
2018-02 |
Issued Notice of Compliance |
| Florbetaben (18F) |
Diagnostic radiopharmaceuticals |
193105 |
2016-04 |
2017-02 |
Issued Notice of Compliance |
| Fluocinolone acetonide |
Ophthalmologicals |
201510 |
2017-02 |
2018-11 |
Issued Notice of Compliance |
| Fluorouracil |
Antineoplastic agents |
211768 |
2018-04 |
2019-02 |
Issued Notice of Compliance |
| Fluoxetine hydrochloride |
Psychoanaleptics |
198520 |
2016-12 |
2017-06 |
Issued Notice of Compliance |
| Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate |
Drugs for obstructive airway diseases |
204880 |
2017-06 |
2018-04 |
Issued Notice of Compliance |
| Fluticasone propionate |
Drugs for obstructive airway diseases |
197873 |
2016-10 |
2017-08 |
Issued Notice of Compliance |
| Fluticasone proprionate, salmeterol xinafoate |
Drugs for obstructive airway diseases |
197974 |
2016-11 |
2018-04 |
Issued Notice of Compliance |
| Follitropin delta |
Sex hormones and modulators of the genital system |
188743 |
2016-01 |
2018-03 |
Issued Notice of Compliance |
| Formoterol fumarate dihydrate, glycopyrronium bromide |
Drugs for obstructive airway diseases |
201306 |
2017-02 |
2018-03 |
Issued Notice of Compliance |
| Foscarnet sodium |
Antivirals for systemic use |
233046 |
2019-12 |
2020-10 |
Issued Notice of Compliance |
| Fosfomycin sodium |
Antibacterials for systemic use |
219662 |
2018-11 |
2019-05 |
Issued Notice of Compliance |
| Fostamatinib disodium |
Antihemorrhagics |
232078 |
2020-01 |
2020-11 |
Issued Notice of Compliance |
| Fostemsavir tromethamine |
Antivirals for systemic use |
250213 |
2021-04 |
2021-10 |
Issued Notice of Compliance |
| Fremanezumab |
Analgesics |
226828 |
2019-06 |
2020-04 |
Issued Notice of Compliance |
| Gadoteric acid |
Contrast media |
186333 |
2015-12 |
2016-11 |
Issued Notice of Compliance |
| Galcanezumab |
Analgesics |
219521 |
2018-10 |
2019-07 |
Issued Notice of Compliance |
| Gallium (68Ga) chloride |
Diagnostic radiopharmaceuticals |
221824 |
2019-04 |
2019-11 |
Issued Notice of Compliance |
| Gallium (68Ga) chloride, germanium (68Ge) chloride |
Diagnostic radiopharmaceuticals |
227804 |
2019-10 |
2020-08 |
Issued Notice of Compliance |
| Gallium (68Ga) gozetotide |
Diagnostic radiopharmaceuticals |
242332 |
2021-02 |
2022-10 |
Issued Notice of Compliance |
| Gallium oxodotreotide |
Diagnostic radiopharmaceuticals |
248874 |
2021-05 |
2022-02 |
Issued Notice of Compliance |
| Ganciclovir |
Ophthalmologicals |
221456 |
2019-02 |
2022-09 |
Issued Notice of Compliance |
| Gemtuzumab ozogamicin |
Antineoplastic agents |
223091 |
2019-02 |
2019-11 |
Issued Notice of Compliance |
| Gilteritinib fumarate |
Antineoplastic agents |
227918 |
2019-06 |
2019-12 |
Issued Notice of Compliance |
| Givosiran |
Bile and liver therapy |
237194 |
2020-04 |
2020-10 |
Issued Notice of Compliance |
| Glasdegib |
Antineoplastic agents |
225793 |
2019-07 |
2020-04 |
Issued Notice of Compliance |
| Glecaprevir, pibrentasvir |
Antivirals for systemic use |
202233 |
2017-02 |
2017-08 |
Issued Notice of Compliance |
| Glofitamab |
Antineoplastic agents |
265517 |
2022-07 |
2023-03 |
Issued Notice of Compliance under the NOC/c Guidance |
| Glucagon |
Pancreatic hormones |
220839 |
2018-11 |
2019-09 |
Issued Notice of Compliance |
| 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 |
231585 |
2020-03 |
2020-12 |
Issued Notice of Compliance |
| Glycopyrrolate |
Drugs for functional gastrointestinal disorders |
197038 |
2017-01 |
2017-10 |
Issued Notice of Compliance |
| Glycopyrronium bromide, indacaterol acetate, mometasone furoate |
Drugs for obstructive airway diseases |
228353 |
2019-09 |
2020-07 |
Issued Notice of Compliance |
| Goserelin acetate |
Endocrine therapy |
232286 |
2020-07 |
2021-10 |
Cancelled by sponsor |
| Guselkumab |
Immunosuppressants |
200590 |
2017-01 |
2017-11 |
Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B |
Vaccines |
200726 |
2017-05 |
2019-03 |
Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
203436 |
2017-04 |
2018-02 |
Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
222669 |
2019-01 |
2019-11 |
Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
234113 |
2020-01 |
2020-11 |
Cancelled by sponsor |
| Haemagglutinin, neuraminidase antigen |
Vaccines |
235556 |
2020-03 |
2021-01 |
Issued Notice of Compliance |
| Halobetasol propionate, tazarotene |
Corticosteroids, dermatological preparations |
212718 |
2018-05 |
2020-06 |
Issued Notice of Compliance |
| Hemin |
Other alimentary tract and metabolism |
212276 |
2018-01 |
2018-07 |
Issued Notice of Compliance |
| Hepatitis B surface antigen (recombinant) |
Vaccines |
259302 |
2022-02 |
2022-12 |
Issued Notice of Compliance |
| Human heterologous liver cells |
Other alimentary tract and metabolism products |
205160 |
2017-06 |
2018-07 |
Cancelled by sponsor |
| Human insulin (recombinant) |
Drugs used in diabetes |
251360 |
2021-05 |
2022-08 |
Issued Notice of Compliance |
| Hyaluronidase (human recombinant), immunoglobulin (human), |
Immune sera and immunoglobulins |
247727 |
2021-02 |
2022-01 |
Issued Notice of Compliance |
| Hydrochlorothiazide, zofenopril calcium |
Agents acting on the renin-angiotensin system |
212396 |
2018-06 |
2019-06 |
Cancelled by sponsor |
| Hydrogen peroxide |
Other dermatological preparations |
216854 |
2018-12 |
2019-08 |
Cancelled by sponsor |
| Icosapent ethyl |
Lipid modifying agents |
227235 |
2019-07 |
2019-12 |
Issued Notice of Compliance |
| Idarucizumab |
All other therapeutic products |
182503 |
2015-05 |
2016-04 |
Issued Notice of Compliance under the NOC/c Guidance |
| Idecabtagene vicleucel |
Antineoplastic agents |
244266 |
2020-10 |
2021-05 |
Issued Notice of Compliance under the NOC/c Guidance |
| Immunoglobulin (human) |
Immune sera and immunoglobulins |
194291 |
2016-10 |
2017-08 |
Issued Notice of Compliance |
| Immunoglobulin (human) |
Immune sera and immunoglobulins |
226576 |
2019-06 |
2019-12 |
Issued Notice of Compliance |
| Immunoglobulin G (human) |
Immune sera and immunoglobulins |
202924 |
2017-04 |
2018-02 |
Issued Notice of Compliance |
| Inclisiran sodium |
Lipid modifying agents |
243470 |
2020-09 |
2021-07 |
Issued Notice of Compliance |
| Indacaterol acetate, mometasone furoate |
Drugs for obstructive airway diseases |
227987 |
2019-07 |
2020-05 |
Issued Notice of Compliance |
| Infigratinib phosphate |
Antineoplastic agents |
246904 |
2021-01 |
2021-09 |
Issued Notice of Compliance under the NOC/c Guidance |
| Infliximab |
Immunosuppressants |
226189 |
2019-05 |
2020-03 |
Issued Notice of Compliance |
| Infliximab |
Immunosuppressants |
248134 |
2021-02 |
2021-12 |
Issued Notice of Compliance |
| Inotersen sodium |
Other nervous system drugs |
214274 |
2018-04 |
2018-10 |
Issued Notice of Compliance |
| Inotuzumab ozogamicin |
Antineoplastic agents |
204077 |
2017-05 |
2018-03 |
Issued Notice of Compliance |
| Insulin aspart |
Drugs used in diabetes |
226573 |
2019-12 |
2020-10 |
Issued Notice of Compliance |
| Insulin aspart |
Drugs used in diabetes |
243229 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
| Insulin degludec |
Drugs used in diabetes |
198124 |
2016-10 |
2017-08 |
Issued Notice of Compliance |
| Insulin degludec, liraglutide |
Drugs used in diabetes |
194513 |
2017-06 |
2018-04 |
Issued Notice of Compliance |
| Insulin glargine |
Drugs used in diabetes |
202772 |
2017-04 |
2019-02 |
Cancelled by sponsor |
| Insulin glargine |
Drugs used in diabetes |
252068 |
2021-06 |
2022-04 |
Issued Notice of Compliance |
| Insulin glargine, lixisenatide |
Drugs used in diabetes |
207006 |
2017-09 |
2018-07 |
Issued Notice of Compliance |
| Insulin injection human biosynthetic |
Drugs used in diabetes |
189076 |
2016-09 |
2017-07 |
Issued Notice of Compliance |
| Insulin lispro |
Drugs used in diabetes |
200792 |
2017-01 |
2017-11 |
Issued Notice of Compliance |
| Insulin lispro |
Drugs used in diabetes |
244611 |
2020-11 |
2021-09 |
Issued Notice of Compliance |
| Iodine |
Contrast media |
196107 |
2016-09 |
2017-07 |
Issued Notice of Compliance |
| Ioflupane (123I) |
Diagnostic radiopharmaceuticals |
201481 |
2017-02 |
2017-12 |
Issued Notice of Compliance |
| Iron dextran |
Antianemic preparations |
189897 |
2016-05 |
2017-06 |
Cancelled by sponsor |
| Iron isomaltoside 1000 |
Antianemic preparations |
193890 |
2016-07 |
2018-06 |
Issued Notice of Compliance |
| Isatuximab |
Antineoplastic agents |
229245 |
2019-07 |
2020-04 |
Issued Notice of Compliance |
| Isavuconazonium sulfate |
Antimycotics for systemic use |
208919 |
2018-02 |
2018-12 |
Issued Notice of Compliance |
| Ivacaftor, tezacaftor |
Other respiratory system products |
211292 |
2017-12 |
2018-06 |
Issued Notice of Compliance |
| Ivermectin |
Anthelmintics |
211000 |
2017-12 |
2018-09 |
Issued Notice of Compliance |
| Ixazomib citrate |
Antineoplastic agents |
190498 |
2016-02 |
2016-08 |
Issued Notice of Compliance |
| Ixekizumab |
Immunosuppressants |
184993 |
2015-07 |
2016-05 |
Issued Notice of Compliance |
| Lanadelumab |
Other hematological agents |
213920 |
2018-03 |
2018-09 |
Issued Notice of Compliance |
| Larotrectinib |
Antineoplastic agents |
219998 |
2018-11 |
2019-07 |
Issued Notice of Compliance under the NOC/c Guidance |
| Lasmiditan |
Analgesics |
236369 |
2020-04 |
2021-01 |
Cancelled by sponsor |
| Latanoprostene bunod |
Ophthalmologicals |
211732 |
2018-03 |
2018-12 |
Issued Notice of Compliance |
| Lefamulin acetate |
Antibacterials for systemic use |
233292 |
2020-01 |
2020-07 |
Issued Notice of Compliance |
| Lemborexant |
Psycholeptics |
231286 |
2020-01 |
2020-11 |
Issued Notice of Compliance |
| Lenacapavir sodium |
Antivirals for systemic use |
262999 |
2022-05 |
2022-11 |
Issued Notice of Compliance |
| Letermovir |
Antivirals for systemic use |
204165 |
2017-05 |
2017-11 |
Issued Notice of Compliance |
| LetibotulinumtoxinA |
Muscle relaxants |
251157 |
2021-08 |
2022-06 |
Issued Notice of Compliance |
| Leuprolide mesylate |
Endocrine therapy |
246800 |
2021-01 |
2021-11 |
Issued Notice of Compliance |
| Levetiracetam |
Antiepileptics |
213656 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
| Levothyroxine sodium |
Thyroid therapy |
232047 |
2020-01 |
2020-11 |
Issued Notice of Compliance |
| Lifitegrast |
Ophthalmologicals |
199810 |
2016-12 |
2017-12 |
Issued Notice of Compliance |
| Lisocabtagene maraleucel |
Antineoplastic agents |
247562 |
2021-02 |
2022-05 |
Issued Notice of Compliance |
| Lixisenatide |
Drugs used in diabetes |
193862 |
2016-06 |
2017-05 |
Issued Notice of Compliance |
| Lonoctocog alfa |
Antihemorrhagics |
190891 |
2016-02 |
2016-12 |
Issued Notice of Compliance |
| Lorcaserin hydrochloride |
Antiobesity preparations, excluding diet products |
198689 |
2016-11 |
2018-02 |
Cancelled by sponsor |
| Lorlatinib |
Antineoplastic agents |
215733 |
2018-06 |
2019-02 |
Issued Notice of Compliance under the NOC/c Guidance |
| Lurbinectedin |
Antineoplastic agents |
247485 |
2021-01 |
2021-09 |
Issued Notice of Compliance under the NOC/c Guidance |
| Lumasiran |
Other alimentary tract and metabolism products |
254883 |
2021-08 |
2022-03 |
Issued Notice of Compliance |
| Luspatercept |
Antianemic preparations |
236441 |
2020-03 |
2020-09 |
Issued Notice of Compliance |
| Luspatercept |
Antianemic preparations |
236625 |
2020-04 |
2021-02 |
Issued Notice of Compliance |
| Lutetium (177Lu) oxodotretotide |
Therapeutic radiopharmaceuticals |
217184 |
2018-07 |
2019-01 |
Issued Notice of Compliance |
| Lutetium (177Lu) vipivotide tetraxetan |
Therapeutic radiopharmaceuticals |
260951 |
2022-02 |
2022-08 |
Issued Notice of Compliance |
| Macitentan, tadalafil |
Antihypertensives |
245848 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
| Mannitol |
Diagnostic agents |
217446 |
2018-08 |
2019-06 |
Issued Notice of Compliance |
| Maribavir |
Antivirals for systemic use |
259676 |
2022-03 |
2022-09 |
Issued Notice of Compliance |
| Mavacamten |
Cardiac therapy |
258772 |
2022-01 |
2022-11 |
Issued Notice of Compliance |
| Mecasermin |
Pituitary, hypothalamic hormones and analogues |
235023 |
2020-02 |
2020-12 |
Issued Notice of Compliance |
| 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 |
233632 |
2020-01 |
2020-10 |
Issued Notice of Compliance |
| Mercaptamine bitartrate |
Other alimentary tract and metabolism products |
191347 |
2016-03 |
2017-06 |
Issued Notice of Compliance |
| Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
204605 |
2017-05 |
2018-03 |
Issued Notice of Compliance |
| Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
198475 |
2017-02 |
2020-08 |
Cancelled by sponsor |
| Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
194646 |
2016-09 |
2021-05 |
Issued Notice of Compliance |
| Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
247241 |
2021-03 |
2022-01 |
Issued Notice of Compliance |
| Metformin hydrochloride |
Drugs used in diabetes |
263913 |
2022-07 |
2023-01 |
Issued Notice of Compliance |
| Methotrexate sodium |
Immunosuppressants |
254599 |
2021-11 |
2022-09 |
Issued Notice of Compliance |
| Methoxyflurane |
Analgesics |
204879 |
2017-06 |
2018-04 |
Issued Notice of Compliance |
| Methylene blue |
Diagnostic agents |
219788 |
2018-10 |
2021-05 |
Issued Notice of Non-compliance - Withdrawal |
| Midostaurin |
Antineoplastic agents |
201101 |
2017-01 |
2017-07 |
Issued Notice of Compliance |
| Migalastat hydrochloride |
Other alimentary tract and metabolism products |
196956 |
2016-11 |
2017-09 |
Issued Notice of Compliance |
| Mogamulizumab |
Antineoplastic agents |
251277 |
2021-05 |
2022-06 |
Issued Notice of Compliance |
| Mometasone furoate |
Corticosteroids, dermatological preparations |
199704 |
2017-09 |
2019-10 |
Cancelled by sponsor |
| Mometasone furoate monohydrate, olopatadine hydrochloride |
Nasal preparations |
238027 |
2020-07 |
2022-09 |
Issued Notice of Compliance |
| Naloxone hydrochloride |
All other therapeutic products |
193199 |
2016-04 |
2016-10 |
Issued Notice of Compliance |
| Naloxone hydrochloride dihydrate |
All other therapeutic products |
211970 |
2018-01 |
2019-06 |
Cancelled by sponsor |
| Naproxen sodium, sumatriptan succinate |
Analgesics |
225848 |
2019-05 |
2020-02 |
Issued Notice of Compliance |
| Necitumumab |
Antineoplastic agents |
193689 |
2016-05 |
2017-03 |
Issued Notice of Compliance |
| Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B |
Vaccines |
195550 |
2016-07 |
2017-10 |
Issued Notice of Compliance |
| Neratinib maleate |
Antineoplastic agents |
218224 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
| Netupitant, palonosetron hydrochloride |
Antiemetics and antinauseants |
196495 |
2016-12 |
2017-09 |
Issued Notice of Compliance |
| Nicardipine hydrochloride |
Calcium channel blockers |
216257 |
2018-07 |
2020-04 |
Issued Notice of Non-compliance - Withdrawal |
| Niraparib |
Antineoplastic agents |
216792 |
2018-09 |
2019-06 |
Issued Notice of Compliance |
| Nirmatrelvir, ritonavir |
Antivirals for systemic use |
259186 |
2021-12 |
2022-01 |
Issued Notice of Compliance |
| Nitisinone |
Other alimentary tract and metabolism products |
190564 |
2016-03 |
2016-09 |
Issued Notice of Compliance |
| Nitisinone |
Other alimentary tract and metabolism products |
193226 |
2016-07 |
2016-12 |
Issued Notice of Compliance |
| Nitisinone |
Other alimentary tract and metabolism products |
193770 |
2016-05 |
2016-11 |
Issued Notice of Compliance |
| Nusinersen |
Other drugs for disorders of the musculo-skeletal systemOther |
200070 |
2016-12 |
2017-06 |
Issued Notice of Compliance |
| Obeticholic acid |
Bile and liver therapy |
198418 |
2016-10 |
2017-05 |
Issued Notice of Compliance under the NOC/c Guidance |
| Obiltoxaximab |
Immune sera and immunoglobulins |
230825 |
2019-10 |
2020-07 |
Issued Notice of Compliance |
| Ocrelizumab |
Immunosuppressants |
198094 |
2016-10 |
2017-08 |
Issued Notice of Compliance |
| Ocrelizumab |
Immunosuppressants |
197969 |
2016-10 |
2018-02 |
Issued Notice of Compliance under the NOC/c Guidance |
| Ofatumumab |
Antineoplastic agents |
237346 |
2020-05 |
2021-01 |
Issued Notice of Compliance |
| Olaparib |
Antineoplastic agents |
182823 |
2015-06 |
2016-04 |
Issued Notice of Compliance under the NOC/c Guidance |
| Olaratumab |
Antineoplastic agents |
203478 |
2017-04 |
2017-11 |
Issued Notice of Compliance under the NOC/c Guidance |
| Onasemnogene abeparvovec |
Other drugs for disorders of the musculo-skeletal system |
239719 |
2020-06 |
2020-12 |
Issued Notice of Compliance |
| Osimertinib |
Antineoplastic agents |
188171 |
2015-11 |
2016-07 |
Issued Notice of Compliance under the NOC/c Guidance |
| Ospemifene |
Sex hormones and modulators of the genital system |
222001 |
2019-03 |
2021-07 |
Issued Notice of Compliance |
| Oxycodone |
Analgesics |
198865 |
2016-11 |
2018-07 |
Cancelled by sponsor |
| Ozanimod hydrochloride |
Immunosuppressants |
232761 |
2019-12 |
2020-10 |
Issued Notice of Compliance |
| Ozenoxacin |
Antibiotics and chemotherapy for dermatological use |
192925 |
2016-07 |
2017-05 |
Issued Notice of Compliance |
| Palovarotene |
Other drugs for disorders of the musculo-skeletal system |
252065 |
2021-07 |
2022-01 |
Issued Notice of Compliance |
| Panobinostat |
Antineoplastic agents |
187504 |
2015-11 |
2016-06 |
Cancelled by sponsor |
| Patiromer sorbitex calcium |
All other therapeutic products |
210368 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
| Patisiran |
Other nervous system drugs |
221896 |
2018-12 |
2019-06 |
Issued Notice of Compliance |
| Pegaspargase |
Antineoplastic agents |
189795 |
2016-05 |
2017-02 |
Issued Notice of Compliance |
| Pegcetaclopan |
Immunosuppressants |
263432 |
2022-06 |
2022-12 |
Issued Notice of Compliance |
| Pegfilgrastim |
Immunostimulants |
204841 |
2017-06 |
2018-04 |
Issued Notice of Compliance |
| Pegfilgrastim |
Immunostimulants |
200807 |
2017-01 |
2018-12 |
Issued Notice of Compliance |
| Pegfilgrastim |
Immunostimulants |
220445 |
2019-05 |
2020-04 |
Issued Notice of Compliance |
| Pegfilgrastim |
Immunostimulants |
233373 |
2020-01 |
2020-10 |
Issued Notice of Compliance |
| Pegfilgrastim |
Immunostimulants |
232048 |
2019-11 |
2021-07 |
Cancelled by sponsor |
| Pegvaliase |
Other alimentary tract and metabolism products |
251687 |
2021-06 |
2022-03 |
Issued Notice of Compliance |
| Pemigatinib |
Antineoplastic agents |
242569 |
2020-10 |
2021-09 |
Issued Notice of Compliance under the NOC/c Guidance |
| Peramivir |
Antivirals for systemic use |
191280 |
2016-03 |
2017-01 |
Issued Notice of Compliance |
| Perindopril arginine |
Agents acting on the renin-angiotensin system |
201189 |
2017-08 |
2018-03 |
Issued Notice of Compliance |
| Pertuzumab, trastuzumab |
Antineoplastic agents |
237402 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
| Pitolisant |
Other nervous system drugs |
238175 |
2020-05 |
2021-05 |
Issued Notice of Compliance |
| Plecanatide |
Drugs for constipation |
215288 |
2018-12 |
2019-10 |
Issued Notice of Compliance |
| Polatuzumab vedotin |
Antineoplastic agents |
232303 |
2019-11 |
2020-07 |
Issued Notice of Compliance under the NOC/c Guidance |
| Ponesimod |
Immunosuppressants |
239537 |
2020-07 |
2021-04 |
Issued Notice of Compliance |
| PrabotulinumtoxinA |
Muscle relaxants |
208364 |
2017-10 |
2018-08 |
Issued Notice of Compliance |
| Pralatrexate |
Antineoplastic agents |
207545 |
2017-11 |
2018-10 |
Issued Notice of Compliance under the NOC/c Guidance |
| Pralsetinib |
Antineoplastic agents |
243731 |
2020-11 |
2021-06 |
Issued Notice of Compliance under the NOC/c Guidance |
| Pralsetinib |
Antineoplastic agents |
252270 |
2021-06 |
2022-04 |
Cancelled by sponsor |
| Prasterone |
Anabolic agents for systemic use |
198822 |
2016-12 |
2019-11 |
Issued Notice of Compliance |
| Progesterone |
Sex hormones and modulators of the genital system |
211548 |
2018-02 |
2018-08 |
Issued Notice of Compliance |
| Progesterone |
Sex hormones and modulators of the genital system |
239820 |
2020-07 |
2021-04 |
Issued Notice of Compliance |
| Propiverine hydrochloride |
Urologicals |
188323 |
2016-03 |
2017-01 |
Issued Notice of Compliance |
| Rabies immunoglobulin, human |
Immune sera and immunoglobulins |
211541 |
2018-01 |
2018-11 |
Issued Notice of Compliance |
| Ranibizumab |
Ophthalmologicals |
251162 |
2021-05 |
2022-03 |
Issued Notice of Compliance |
| Ranibizumab |
Ophthalmologicals |
254848 |
2021-09 |
2022-09 |
Issued Notice of Compliance |
| Ranolazine |
Cardiac therapy |
239943 |
2020-07 |
2020-12 |
Issued Notice of Compliance |
| Ravulizumab |
Immunosuppressants |
217955 |
2018-11 |
2019-08 |
Issued Notice of Compliance |
| Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) |
Antihemorrhagics |
180793 |
2015-04 |
2016-01 |
Issued Notice of Compliance |
| 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 |
230211 |
2019-09 |
2021-09 |
Cancelled by sponsor |
| 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 |
235672 |
2020-03 |
2021-01 |
Issued Notice of Compliance |
| Remdesivir |
Antivirals for systemic use |
240551 |
2020-07 |
2020-07 |
Issued Notice of Compliance under the NOC/c Guidance |
| Reslizumab |
Immunosuppressants |
185873 |
2015-09 |
2016-07 |
Issued Notice of Compliance |
| Ribociclib |
Antineoplastic agents |
203884 |
2017-05 |
2018-03 |
Issued Notice of Compliance |
| Riltozinameran, tozinameran |
Vaccines |
266189 |
2022-07 |
2022-10 |
Issued Notice of Compliance |
| Ripretinib |
Antineoplastic agents |
234688 |
2020-03 |
2020-06 |
Issued Notice of Compliance |
| Risankizumab |
Immunosuppressants |
215753 |
2018-06 |
2019-04 |
Issued Notice of Compliance |
| Risdiplam |
Other drugs for disorders of the musculo-skeletal system |
242373 |
2020-10 |
2021-04 |
Issued Notice of Compliance |
| Risperidone |
Psycholeptics |
233331 |
2020-01 |
2020-11 |
Issued Notice of Compliance |
| Rituximab |
Antineoplastic agents |
207702 |
2017-09 |
2019-03 |
Cancelled by sponsor |
| Rituximab |
Antineoplastic agents |
208107 |
2017-09 |
2019-03 |
Cancelled by sponsor |
| Rituximab |
Antineoplastic agents |
208204 |
2017-09 |
2019-04 |
Issued Notice of Compliance |
| Rituximab |
Antineoplastic agents |
224672 |
2019-03 |
2019-04 |
Cancelled by sponsor |
| Rituximab |
Antineoplastic agents |
214058 |
2018-04 |
2020-04 |
Issued Notice of Compliance |
| Rituximab |
Antineoplastic agents |
224164 |
2019-03 |
2020-05 |
Issued Notice of Compliance |
| Rituximab |
Antineoplastic agents |
237814 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
| Romosozumab |
Drugs for treatment of bone diseases |
197713 |
2016-10 |
2019-06 |
Issued Notice of Compliance |
| Roxadustat |
Antianemic preparations |
236566 |
2020-03 |
2021-10 |
Cancelled by sponsor |
| Rupatadine fumarate |
Antihistamines for systemic use |
186488 |
2015-09 |
2016-07 |
Issued Notice of Compliance |
| Sacituzumab govitecan |
Antineoplastic agents |
248753 |
2021-03 |
2021-09 |
Issued Notice of Compliance |
| Safinamide |
Anti-parkinson drugs |
207115 |
2018-03 |
2019-01 |
Issued Notice of Compliance |
| Salbutamol sulfate |
Drugs for obstructive airway diseases |
189577 |
2016-11 |
2017-11 |
Issued Notice of Compliance |
| Sarilumab |
Immunosuppressants |
191745 |
2016-03 |
2017-01 |
Issued Notice of Compliance |
| SARS-CoV-2 prefusion spike delta TM protein, recombinant |
Vaccines |
254715 |
2021-07 |
2023-02 |
Cancelled by sponsor |
| SARS-CoV-2 prefusion spike delta TM protein, recombinant |
Vaccines |
269939 |
2022-12 |
2023-02 |
Cancelled by sponsor |
| SARS-CoV-2 recombinant spike protein |
Vaccines |
255370 |
2021-10 |
2022-02 |
Issued Notice of Compliance |
| Satralizumab |
Immunosuppressants |
233642 |
2019-12 |
2020-06 |
Issued Notice of Compliance |
| Sebelipase alfa |
Other alimentary tract and metabolism products |
204085 |
2017-04 |
2017-12 |
Issued Notice of Compliance under the NOC/c Guidance |
| Selinexor |
Antineoplastic agents |
253182 |
2021-08 |
2022-05 |
Issued Notice of Compliance |
| Selpercatinib |
Antineoplastic agents |
243748 |
2020-10 |
2021-06 |
Issued Notice of Compliance under the NOC/c Guidance |
| Selumetinib |
Antineoplastic agents |
243733 |
2020-11 |
2022-08 |
Issued Notice of Compliance |
| Semaglutide |
Drugs used in diabetes |
202059 |
2017-03 |
2018-01 |
Issued Notice of Compliance |
| Semaglutide |
Drugs used in diabetes |
226906 |
2019-06 |
2020-03 |
Issued Notice of Compliance |
| Semaglutide |
Drugs used in diabetes |
247235 |
2021-01 |
2021-11 |
Issued Notice of Compliance |
| Siponimod |
Immunosuppressants |
223225 |
2019-02 |
2020-02 |
Issued Notice of Compliance |
| Sirukumab |
Immunosuppressants |
205568 |
2017-06 |
2017-10 |
Cancelled by sponsor |
| Sodium chloride, sodium citrate |
Blood substitutes and perfusion solutions |
225953 |
2019-05 |
2020-03 |
Issued Notice of Compliance |
| Sodium pertechnetate Tc-99m |
Diagnostic radiopharmaceuticals |
231915 |
2020-01 |
2020-11 |
Issued Notice of Compliance |
| Sodium phenylbutyrate, ursodoxicoltaurine |
Other nervous system drugs |
253502 |
2021-08 |
2022-06 |
Issued Notice of Compliance under the NOC/c Guidance |
| Sodium zirconium cyclosilicate |
All other therapeutic products |
218799 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
| Sofosbuvir, velpatasvir |
Antivirals for systemic use |
190521 |
2016-01 |
2016-07 |
Issued Notice of Compliance |
| Sofosbuvir, velpatasvir, voxilaprevir |
Antivirals for systemic use |
202324 |
2017-02 |
2017-08 |
Issued Notice of Compliance |
| Solriamfetol hydrochloride |
Psychoanaleptics |
237511 |
2020-07 |
2021-05 |
Issued Notice of Compliance |
| Somatrogon |
Pituitary, hypothalamic hormones and analogues |
246729 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
| Sonidegib |
Antineoplastic agents |
229407 |
2019-08 |
2020-06 |
Issued Notice of Compliance |
| Sotagliflozin |
Drugs used in diabetes |
217853 |
2018-08 |
2019-06 |
Cancelled by sponsor |
| Sotorasib |
Antineoplastic agents |
248435 |
2021-02 |
2021-09 |
Issued Notice of Compliance under the NOC/c Guidance |
| Spesolimab |
Immunosuppressants |
267362 |
2022-09 |
2023-03 |
Issued Notice of Compliance |
| Sucroferric oxyhydroxide |
All other therapeutic products |
201492 |
2017-02 |
2018-01 |
Issued Notice of Compliance |
| Sugammadex |
All other therapeutic products |
180385 |
2015-04 |
2016-02 |
Issued Notice of Compliance |
| Suvorexant |
Psycholeptics |
196367 |
2016-08 |
2018-11 |
Issued Notice of Compliance |
| Tacrolimus |
Immunosuppressants |
209210 |
2018-04 |
2019-02 |
Issued Notice of Compliance |
| Tafamidis |
Other nervous system drugs |
240239 |
2020-09 |
2021-07 |
Issued Notice of Compliance |
| Tafamidis meglumine |
Other nervous system drugs |
228368 |
2019-07 |
2020-01 |
Issued Notice of Compliance |
| Tafasitamab |
Antineoplastic agents |
247025 |
2020-12 |
2021-08 |
Issued Notice of Compliance |
| Talazoparib |
Antineoplastic agents |
220584 |
2018-11 |
2019-09 |
Issued Notice of Compliance |
| Tazarotene |
Antipsoriatics |
236286 |
2020-09 |
2021-07 |
Issued Notice of Compliance |
| Tebentafusp |
Antineoplastic agents |
258717 |
2021-12 |
2022-06 |
Issued Notice of Compliance |
| Tecovirimat monohydrate |
Antivirals for systemic use |
247561 |
2021-02 |
2021-11 |
Issued Notice of Compliance |
| Telotristat etiprate |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
208730 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
| Tenapanor |
Drugs for constipation |
224850 |
2019-06 |
2020-04 |
Issued Notice of Compliance |
| Tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
193066 |
2016-07 |
2017-05 |
Issued Notice of Compliance |
| Tepotinib |
Antineoplastic agents |
242300 |
2020-10 |
2021-05 |
Issued Notice of Compliance under the NOC/c Guidance |
| Teriparatide |
Calcium homeostasis |
215409 |
2018-06 |
2020-01 |
Issued Notice of Compliance |
| Tezepelumab |
Drugs for obstructive airway diseases |
256188 |
2021-10 |
2022-07 |
Issued Notice of Compliance |
| Tibolone |
Sex hormones and modulators of the genital system |
206099 |
2017-10 |
2019-05 |
Issued Notice of Compliance |
| Tildrakizumab |
Immunosuppressants |
224036 |
2019-02 |
2021-05 |
Issued Notice of Compliance |
| Tipiracil hydrochloride, trifluridine |
Antineoplastic agents |
205852 |
2017-07 |
2018-01 |
Issued Notice of Compliance |
| Tirzepatide |
Drugs used in diabetes |
259103 |
2022-02 |
2022-11 |
Issued Notice of Compliance |
| Tisagenlecleucel-T |
Antineoplastic agents |
213547 |
2018-03 |
2018-09 |
Issued Notice of Compliance |
| Tisagenlecleucel-T |
Antineoplastic agents |
213698 |
2018-03 |
2018-09 |
Issued Notice of Compliance |
| Tozinameran |
Vaccines |
252736 |
2021-06 |
2021-09 |
Issued Notice of Compliance |
| Tralokinumab |
Other dermatological preparations |
245877 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
| Trastuzumab |
Antineoplastic agents |
204579 |
2017-06 |
2019-05 |
Issued Notice of Compliance |
| Trastuzumab |
Antineoplastic agents |
212140 |
2018-02 |
2019-08 |
Issued Notice of Compliance |
| Trastuzumab |
Antineoplastic agents |
210238 |
2017-11 |
2019-09 |
Issued Notice of Compliance |
| Trastuzumab |
Antineoplastic agents |
208836 |
2017-10 |
2020-02 |
Issued Notice of Compliance |
| Trastuzumab |
Antineoplastic agents |
235995 |
2020-04 |
2022-01 |
Issued Notice of Compliance |
| Trastuzumab deruxtecan |
Antineoplastic agents |
242104 |
2020-08 |
2021-04 |
Issued Notice of Compliance under the NOC/c Guidance |
| Treosulfan |
Antineoplastic agents |
244137 |
2020-12 |
2021-06 |
Issued Notice of Compliance |
| Treosulfan |
Antineoplastic agents |
231223 |
2020-01 |
2021-06 |
Issued a Notice of Deficiency - Withdrawal |
| Triamcinolone hexacetonide |
Corticosteroids for systemic use |
201546 |
2017-02 |
2017-12 |
Issued Notice of Compliance |
| Trientine hydrochloride |
Other alimentary tract and metabolism products |
228708 |
2019-11 |
2020-09 |
Issued Notice of Compliance |
| Trientine hydrochloride |
All other therapeutic products |
237287 |
2020-06 |
2021-04 |
Issued Notice of Compliance |
| Trifarotene |
Anti-acne preparations |
221945 |
2019-01 |
2019-11 |
Issued Notice of Compliance |
| Triheptanoin |
Other alimentary tract and metabolism |
242196 |
2020-08 |
2021-02 |
Issued Notice of Compliance |
| Tucatinib |
Antineoplastic agents |
235295 |
2020-02 |
2020-06 |
Issued Notice of Compliance |
| Ubrogepant |
Analgesics |
256191 |
2021-10 |
2022-11 |
Issued Notice of Compliance |
| Upadacitinib |
Immunosuppressants |
223734 |
2019-03 |
2019-12 |
Issued Notice of Compliance |
| Varicella-zoster virus glycoprotein E (GE) |
Vaccines |
200244 |
2016-12 |
2017-10 |
Issued Notice of Compliance |
| Venetoclax |
Antineoplastic agents |
190761 |
2016-02 |
2016-09 |
Issued Notice of Compliance under the NOC/c Guidance |
| Vernakalant hydrochloride |
Cardiac therapy |
190817 |
2016-05 |
2017-03 |
Issued Notice of Compliance |
| Virus-like particles (VLP) of SARS-CoV-2 spike protein |
Vaccines |
254598 |
2021-09 |
2022-02 |
Issued Notice of Compliance |
| Vitamin D3 |
Vitamins |
219321 |
2019-01 |
2021-02 |
Issued Notice of Compliance |
| Vitamin K1 |
Antihemorrhagics |
225983 |
2019-08 |
2021-06 |
Issued a Notice of Deficiency - Withdrawal |
| Volanesorsen |
Lipid modifying agents |
209280 |
2017-11 |
2018-11 |
Issued Notice of Non-compliance - Withdrawal |
| Vonicog alfa |
Antihemorrhagics |
213188 |
2018-03 |
2019-01 |
Issued Notice of Compliance |
| Voretigene neparvovec |
Ophthalmologicals |
233097 |
2019-12 |
2020-10 |
Issued Notice of Compliance |
| Zanubrutinib |
Antineoplastic agents |
242748 |
2020-09 |
2021-03 |
Issued Notice of Compliance |
| Zanubrutinib |
Antineoplastic agents |
242885 |
2020-09 |
2021-07 |
Issued Notice of Compliance |
| Zofenopril calcium |
Agents acting on the renin-angiotensin system |
212392 |
2018-06 |
2019-06 |
Cancelled by sponsor |
