Drug and Health Product Submissions Under Review (SUR): Supplemental submissions completed
This list is current as of: 2024-07-31.
An Excel version of the updated SUR List is available from the Overview page.
Medicinal Ingredient(s) | Therapeutic Area | Submission Control Number | Year, Month Submission was Accepted into Review | Year, Month Submission Concluded | Outcome of SubmissionFootnote a |
---|---|---|---|---|---|
Abacavir sulfate, dolutegravir sodium, lamivudine | Antivirals for systemic use | 208070 | 2017-08 | 2017-10 | Issued Notice of Compliance |
Abatacept | Immunosuppressants | 204313 | 2017-05 | 2018-03 | Issued Notice of Compliance |
Abatacept | Immunosuppressants | 255926 | 2021-09 | 2022-07 | Issued Notice of Compliance |
Abemaciclib | Antineoplastic agents | 249557 | 2021-03 | 2022-01 | Issued Notice of Compliance |
Abemaciclib | Antineoplastic agents | 270898 | 2023-03 | 2023-12 | Issued Notice of Compliance |
Abiraterone acetate | Endocrine therapy | 207915 | 2017-08 | 2018-02 | Issued Notice of Compliance |
AbobotulinumtoxinA | Muscle relaxants | 202245 | 2017-03 | 2017-12 | Issued Notice of Compliance |
AbobotulinumtoxinA | Muscle relaxants | 204299 | 2017-05 | 2018-03 | Issued Notice of Compliance |
AbobotulinumtoxinA | Muscle relaxants | 206921 | 2017-08 | 2018-04 | Issued Notice of Compliance |
AbobotulinumtoxinA | Muscle relaxants | 236999 | 2020-04 | 2021-02 | Issued Notice of Compliance |
Acalabrutinib | Antineoplastic agents | 231228 | 2019-10 | 2019-11 | Issued Notice of Compliance |
Ad26.COV2.S (recombinant) | Vaccines | 259715 | 2021-12 | 2022-05 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 197529 | 2016-09 | 2017-07 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 201423 | 2017-02 | 2017-12 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 212133 | 2018-02 | 2018-11 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 213550 | 2018-03 | 2019-01 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 219453 | 2018-10 | 2020-11 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 234183 | 2019-12 | 2020-11 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 234258 | 2020-01 | 2020-11 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 239280 | 2020-06 | 2021-04 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 244618 | 2020-11 | 2021-09 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 257327 | 2021-11 | 2022-08 | Issued Notice of Compliance |
Adalimumab | Immunosuppressants | 256159 | 2021-10 | 2022-09 | Issued Notice of Compliance |
Adalimumab | Immunsuppressants | 258125 | 2021-12 | 2022-10 | Issued Notice of Compliance |
Adalimumab | Immunsuppressants | 259979 | 2022-02 | 2022-11 | Issued Notice of Compliance |
Afatinib dimaleate | Antineoplastic agents | 209785 | 2017-12 | 2018-09 | Issued Notice of Compliance |
Alectinib | Antineoplastic agents | 210816 | 2017-12 | 2018-06 | Issued Notice of Compliance |
Alectinib hydrochloride | Antineoplastic agents | 282375 | 2024-01 | 2024-06 | Issued Notice of Compliance |
Alemtuzumab | Immunosuppressants | 239220 | 2020-07 | 2021-04 | Issued Notice of Compliance |
Alirocumab | Lipid modifying agents | 219669 | 2018-10 | 2019-07 | Issued Notice of Compliance |
Alpha 1-proteinase inhibitor (human) | Antihemorrhagics | 205855 | 2017-06 | 2017-06 | Issued Notice of Compliance |
Amivantamab | Antineoplastic agents | 282121 | 2024-01 | 2024-06 | Issued Notice of Compliance |
Anakinra | Immunosuppressants | 195649 | 2016-07 | 2017-05 | Issued Notice of Compliance |
Anakinra | Immunosuppressants | 237738 | 2020-05 | 2021-10 | Cancelled by sponsor |
Anidulafungin | Antimycotics for systemic use | 262044 | 2022-07 | 2023-05 | Issued Notice of Compliance |
Anthrax antigen filtrate | Vaccines | 234257 | 2020-01 | 2020-11 | Issued Notice of Compliance |
Antihemophilic factor (recombinant) | Antihemorrhagics | 250002 | 2021-03 | 2022-01 | Issued Notice of Compliance |
Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 211971 | 2018-01 | 2018-11 | Issued Notice of Compliance |
Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 245031 | 2020-11 | 2021-11 | Issued Notice of Compliance |
Antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated | Antihemorrhagics | 268221 | 2022-11 | 2023-09 | Issued Notice of Compliance |
Apalutamide | Endocrine therapy | 228077 | 2019-06 | 2019-12 | Issued Notice of Compliance |
Apixaban | Antithrombotic agents | 198842 | 2016-11 | 2018-10 | Issued Notice of Compliance |
Apremilast | Immunosuppressants | 233030 | 2019-12 | 2020-08 | Issued Notice of Compliance |
Aripiprazole | Psycholeptics | 200292 | 2017-01 | 2017-11 | Issued Notice of Compliance |
Atenolol | Beta blocking agents | 278283 | 2023-09 | 2024-01 | Issued Notice of Compliance |
Atenolol | Beta blocking agents | 278032 | 2023-09 | 2024-02 | Issued Notice of Compliance |
Atenolol | Beta blocking agents | 279029 | 2023-10 | 2024-02 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 205038 | 2017-06 | 2018-04 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 217324 | 2018-07 | 2019-05 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 223753 | 2019-02 | 2019-08 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 223911 | 2019-02 | 2019-09 | Issued Notice of Compliance under the NOC/c Guidance |
Atezolizumab | Antineoplastic agents | 226905 | 2019-06 | 2020-04 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 235450 | 2020-02 | 2020-08 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 237371 | 2020-05 | 2021-03 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 254361 | 2021-07 | 2022-01 | Issued Notice of Compliance |
Atezolizumab | Antineoplastic agents | 254159 | 2021-08 | 2022-03 | Issued Notice of Compliance |
Atogepant | Analgesics | 273484 | 2023-07 | 2024-05 | Issued Notice of Compliance |
Avelumab | Antineoplastic agents | 225974 | 2019-04 | 2019-11 | Issued Notice of Compliance under the NOC/c Guidance |
Avelumab | Antineoplastic agents | 226954 | 2019-06 | 2020-06 | Cancelled by sponsor |
Avelumab | Antineoplastic agents | 240024 | 2020-06 | 2020-12 | Issued Notice of Compliance |
Axicabtagene ciloleucel | Antineoplastic agents | 256106 | 2021-10 | 2022-09 | Issued Notice of Compliance under the NOC/c Guidance |
Axicabtagene ciloleucel | Antineoplastic agents | 259651 | 2022-02 | 2022-12 | Issued Notice of Compliance |
Axitinib | Antineoplastic agents | 245813 | 2020-12 | 2021-10 | Issued Notice of Compliance |
Azelastine hydrochloride, fluticasone propionate | Nasal preparations | 221498 | 2018-12 | 2019-10 | Issued Notice of Compliance |
Azelastine hydrochloride, fluticasone propionate | Nasal preparations | 254371 | 2021-08 | 2022-05 | Issued Notice of Compliance |
Baricitinib | Immunosuppressants | 245874 | 2020-12 | 2022-01 | Cancelled by sponsor |
Baricitinib | Immunosuppressants | 256724 | 2021-10 | 2023-06 | Issued Notice of Non-compliance- Withdrawal |
Baricitinib | Immunosuppressants | 270684 | 2023-04 | 2024-01 | Issued Notice of Compliance |
Bazedoxifene acetate, conjugated estrogens | Sex hormones and modulators of the genital system | 210469 | 2017-11 | 2018-09 | Issued Notice of Compliance |
Belimumab | Immunosuppressants | 243390 | 2020-10 | 2021-07 | Issued Notice of Compliance |
Belzutifan | Antineoplastic agents | 270609 | 2023-01 | 2023-07 | Issued Notice of Compliance |
Betamethasone dipropionate, calcipotriol monohydrate | Corticosteroids, dermatological preparations | 247673 | 2021-01 | 2021-10 | Issued Notice of Compliance |
Bevacizumab | Antineoplastic agents | 207259 | 2017-08 | 2018-06 | Issued Notice of Compliance |
Bevacizumab | Antineoplastic agents | 218844 | 2018-09 | 2019-06 | Issued Notice of Compliance |
Bevacizumab | Antineoplastic agents | 230254 | 2019-09 | 2020-02 | Issued Notice of Compliance |
Bevacizumab | Antineoplastic agents | 232977 | 2019-11 | 2021-01 | Issued Notice of Compliance |
Bevacizumab | Antineoplastic agents | 257734 | 2021-12 | 2022-10 | Issued Notice of Compliance |
Bevacizumab | Antineoplastic agents | 259936 | 2022-02 | 2022-11 | Issued Notice of Compliance |
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 226658 | 2019-05 | 2020-03 | Issued Notice of Compliance |
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 240953 | 2020-07 | 2021-05 | Issued Notice of Compliance |
Bilastine | Antihistamines for systemic use | 241318 | 2020-10 | 2021-08 | Issued Notice of Compliance |
Bimekizumab | Immunosuppressants | 273184 | 2023-05 | 2024-02 | Issued Notice of Compliance |
Bimekizumab | Immunosuppressants | 273663 | 2023-05 | 2024-03 | Issued Notice of Compliance |
Bisoprolol fumarate | Beta blocking agents | 243497 | 2021-01 | 2024-01 | Issued Notice of Compliance |
Blinatumomab | Antineoplastic agents | 197615 | 2016-09 | 2017-04 | Issued Notice of Compliance under the NOC/c Guidance |
Blinatumomab | Antineoplastic agents | 204154 | 2017-05 | 2018-03 | Issued Notice of Compliance |
Blinatumomab | Antineoplastic agents | 210780 | 2017-12 | 2019-12 | Issued Notice of Compliance under the NOC/c Guidance |
Bosutinib | Antineoplastic agents | 211317 | 2018-02 | 2018-12 | Issued Notice of Compliance |
Brentuximab vedotin | Antineoplastic agents | 213996 | 2018-04 | 2018-12 | Issued Notice of Compliance |
Brentuximab vedotin | Antineoplastic agents | 216513 | 2018-07 | 2019-05 | Issued Notice of Compliance |
Brentuximab vedotin | Antineoplastic agents | 227030 | 2019-05 | 2019-11 | Issued Notice of Compliance |
Brentuximab vedotin | Antineoplastic agents | 268334 | 2022-12 | 2023-09 | Cancelled by sponsor |
Brexpiprazole | Psycholeptics | 205854 | 2017-07 | 2019-02 | Issued Notice of Compliance |
Brexpiprazole | Psycholeptics | 257995 | 2021-12 | 2022-06 | Cancelled by sponsor |
Brexpiprazole | Psycholeptics | 272694 | 2023-04 | 2024-01 | Issued Notice of Compliance |
Brexucabtagene autoleucel | Antineoplastic agents | 262249 | 2022-04 | 2022-11 | Issued Notice of Compliance |
Brigatinib | Antineoplastic agents | 237680 | 2020-05 | 2021-03 | Issued Notice of Compliance |
Brivaracetam | Antiepileptics | 226734 | 2019-05 | 2020-03 | Issued Notice of Compliance |
Brolucizumab | Ophthalmologicals | 259754 | 2022-02 | 2022-11 | Issued Notice of Compliance |
Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 218994 | 2018-09 | 2020-03 | Cancelled by sponsor |
Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 238101 | 2020-05 | 2021-03 | Issued Notice of Compliance |
Budesonide, formoterol fumarate dihydrate | Drugs for obstructive airway diseases | 220998 | 2018-11 | 2019-09 | Issued Notice of Compliance |
Burosumab | Drugs for the treatment of bone diseases | 229313 | 2019-08 | 2020-06 | Issued Notice of Compliance |
Burosumab | Drugs for treatment of bone diseases | 249112 | 2021-03 | 2021-08 | Issued Notice of Compliance |
C1 esterase inhibitor (human) | Other hematological agents | 197440 | 2016-09 | 2017-03 | Issued Notice of Compliance |
Cabotegravir, rilpivirine | Antivirals for systemic use | 254233 | 2021-08 | 2022-06 | Issued Notice of Compliance |
Cabotegravir, rilpivirine | Antivirals for systemic use | 258574 | 2022-02 | 2022-12 | Issued Notice of Compliance |
Cabozantinib | Antineoplastic agents | 221859 | 2018-12 | 2019-10 | Issued Notice of Compliance |
Cabozantinib | Antineoplastic agents | 222733 | 2019-01 | 2019-11 | Issued Notice of Compliance |
Cabozantinib | Antineoplastic agents | 245824 | 2020-12 | 2021-10 | Issued Notice of Compliance |
Cabozantinib malate | Antineoplastic agents | 257143 | 2021-11 | 2022-04 | Issued Notice of Compliance |
Canagliflozin | Drugs used in diabetes | 194762 | 2016-06 | 2017-04 | Issued Notice of Compliance |
Canagliflozin | Drugs used in diabetes | 210676 | 2017-12 | 2018-10 | Issued Notice of Compliance |
Canagliflozin | Drugs used in diabetes | 229188 | 2019-08 | 2020-01 | Issued Notice of Compliance |
Canagliflozin, metformin hydrochloride | Drugs used in diabetes | 210969 | 2017-12 | 2018-10 | Issued Notice of Compliance |
Canagliflozin, metformin hydrochloride | Drugs used in diabetes | 232307 | 2019-11 | 2020-08 | Issued Notice of Compliance |
Canakinumab | Immunosuppressants | 195617 | 2016-07 | 2017-01 | Issued Notice of Compliance |
Canakinumab | Immunosuppressants | 237113 | 2020-04 | 2021-02 | Issued Notice of Compliance |
Carbetocin | Pituitary and hypothalamic hormones and analogues | 225949 | 2019-05 | 2020-02 | Issued Notice of Compliance |
Carfilzomib | Antineoplastic agents | 237196 | 2020-04 | 2021-01 | Issued Notice of Compliance |
Carfilzomib | Antineoplastic agents | 267413 | 2022-10 | 2023-07 | Issued Notice of Compliance |
Carglumic acid | Other alimentary tract and metabolism products | 227936 | 2019-06 | 2020-11 | Issued Notice of Compliance |
Ceftolozane, tazobactam sodium | Antibacterials for systemic use | 224729 | 2019-03 | 2019-08 | Issued Notice of Compliance |
Cemiplimab | Antineoplastic agents | 246918 | 2020-12 | 2021-10 | Issued Notice of Compliance |
Cemiplimab | Antineoplastic agents | 256178 | 2021-09 | 2022-03 | Issued Notice of Compliance |
Cemiplimab | Antineoplastic agents | 263700 | 2022-05 | 2023-04 | Issued Notice of Compliance |
Certolizumab pegol | Immunosuppressants | 209082 | 2017-10 | 2018-08 | Issued Notice of Compliance |
Certolizumab pegol | Immunosuppressants | 222049 | 2019-01 | 2019-11 | Issued Notice of Compliance |
ChAdOx1-S (recombinant) | Vaccines | 259446 | 2021-12 | 2022-03 | Cancelled by sponsor |
Cilgavimab, tixagevimab | Immune sera and immunoglobulins | 265382 | 2022-06 | 2022-10 | Issued Notice of Compliance |
Ciltacabtagene autoleucel |
Antineoplastic agents |
277017 |
2023-08 |
2024-07 |
Issued Notice of Compliance |
Coagulation factor VIII (human), human plasma proteins, von Willebrand factor (human) | Antihemorrhagics | 274244 | 2023-05 | 2024-02 | Issued Notice of Compliance |
Coagulation factor IX (recombinant), pegylated | Antihemorrhagics | 258126 | 2021-12 | 2022-10 | Issued Notice of Compliance |
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 195789 | 2016-07 | 2017-05 | Issued Notice of Compliance |
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 207251 | 2017-08 | 2018-06 | Issued Notice of Compliance |
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 219784 | 2018-10 | 2019-07 | Issued Notice of Compliance |
Collagenase clostridium histolyticum | Other drugs for disorders of the musculo-skeletal system | 202488 | 2017-03 | 2018-01 | Issued Notice of Compliance |
Concizumab | Antihemorrhagics | 285411 | 2024-05 | 2024-06 | Cancelled by sponsor |
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 | 259725 | 2022-01 | 2022-07 | Issued Notice of Compliance |
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 | 270922 | 2023-01 | 2023-07 | Issued Notice of Compliance |
Corynebacterium diphtheriae crm-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F | Vaccines | 216208 | 2018-06 | 2019-04 | Issued Notice of Compliance |
Crisaborole | Other dermatological preparations | 240171 | 2020-07 | 2021-05 | Issued Notice of Compliance |
Crizotinib | Antineoplastic agents | 198322 | 2016-11 | 2017-08 | Issued Notice of Compliance |
Dabrafenib | Antineoplastic agents | 199381 | 2016-11 | 2017-05 | Issued Notice of Compliance |
Dabrafenib | Antineoplastic agents | 210753 | 2017-11 | 2018-05 | Issued Notice of Compliance |
Dabrafenib | Antineoplastic agents | 213581 | 2018-03 | 2018-09 | Issued Notice of Compliance |
Dabrafenib mesylate | Antineoplastic agents | 270381 | 2023-01 | 2023-07 | Issued Notice of Compliance |
Dalbavancin |
Antibacterials for systemic use |
278103 |
2023-09 |
2024-07 |
Issued Notice of Compliance |
Dapagliflozin propanediol | Drugs used in diabetes | 227213 | 2019-06 | 2020-04 | Issued Notice of Compliance |
Dapagliflozin propanediol | Drugs used in diabetes | 234304 | 2020-01 | 2020-06 | Issued Notice of Compliance |
Dapagliflozin propanediol | Drugs used in diabetes | 248367 | 2021-02 | 2021-08 | Issued Notice of Compliance |
Dapagliflozin propanediol monohydrate | Drugs used in diabetes | 268982 | 2022-12 | 2023-10 | Issued Notice of Compliance |
Dapagliflozin, metformin hydrochloride | Drugs used in diabetes | 228055 | 2019-07 | 2020-04 | Issued Notice of Compliance |
Daptomycin | Antibacterials for systemic use | 214792 | 2018-05 | 2019-02 | Issued Notice of Compliance |
Daratumumab | Antineoplastic agents | 198647 | 2016-10 | 2017-04 | Issued Notice of Compliance |
Daratumumab | Antineoplastic agents | 212559 | 2018-01 | 2018-11 | Issued Notice of Compliance |
Daratumumab | Antineoplastic agents | 226512 | 2019-05 | 2019-10 | Issued Notice of Compliance |
Daratumumab | Antineoplastic agents | 234407 | 2020-01 | 2020-11 | Issued Notice of Compliance |
Daratumumab | Antineoplastic agents | 244119 | 2020-11 | 2021-04 | Issued Notice of Compliance |
Daratumumab | Antineoplastic agents | 249815 | 2021-03 | 2022-01 | Issued Notice of Compliance |
Daratumumab | Antineoplastic agents | 259880 | 2022-02 | 2022-12 | Issued Notice of Compliance |
Darolutamide | Endocrine therapy | 262749 | 2022-04 | 2022-09 | Issued Notice of Compliance |
Davesomeran, elasomeran | Vaccines | 273747 | 2023-03 | 2023-05 | Issued Notice of Compliance |
Davesomeran, elasomeran | Vaccines | 274717 | 2023-05 | 2023-10 | Cancelled by sponsor |
Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | 266249 | 2022-09 | 2023-07 | Issued Notice of Compliance |
Dostarlimab | Antineoplastic agents | 274515 | 2023-05 | 2023-11 | Issued Notice of Compliance |
Deferiprone | All other therapeutic products | 244597 | 2020-12 | 2021-10 | Issued Notice of Compliance |
Deferiprone | All other therapeutic products | 261912 | 2022-06 | 2023-03 | Issued Notice of Compliance |
Denosumab | Drugs for treatment of bone diseases | 203717 | 2017-04 | 2018-02 | Issued Notice of Compliance |
Denosumab | Drugs for treatment of bone diseases | 205235 | 2017-06 | 2018-04 | Issued Notice of Compliance |
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | 241617 | 2020-09 | 2022-12 | Issued Notice of Compliance |
Dexlansoprazole | Drugs for acid related disorders | 215955 | 2018-06 | 2019-04 | Issued Notice of Compliance |
Dimethyl fumarate | Other nervous system drugs | 213790 | 2018-04 | 2019-02 | Issued Notice of Compliance |
Dimethyl fumarate | Immunosuppressants | 259869 | 2022-04 | 2023-05 | Issued Notice of Compliance |
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 | 220233 | 2018-11 | 2020-09 | Issued Notice of Compliance |
Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid | Vaccines | 220103 | 2018-11 | 2020-09 | Issued Notice of Compliance |
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 | 243463 | 2020-10 | 2021-08 | Issued Notice of Compliance |
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed | Vaccines | 243456 | 2020-10 | 2021-08 | Issued Notice of Compliance |
Dolutegravir | Antivirals for systemic use | 207076 | 2017-08 | 2018-05 | Issued Notice of Compliance |
Dolutegravir | Antivirals for systemic use | 235583 | 2020-04 | 2021-01 | Issued Notice of Compliance |
Doravirine | Antivirals for systemic use | 264733 | 2022-07 | 2023-05 | Issued Notice of Compliance |
Dulaglutide | Drugs used in diabetes | 201964 | 2017-03 | 2017-12 | Issued Notice of Compliance |
Dulaglutide | Drugs used in diabetes | 232128 | 2019-11 | 2020-09 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 221043 | 2018-11 | 2019-09 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 231268 | 2019-10 | 2020-08 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 234105 | 2020-01 | 2020-11 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 237081 | 2020-04 | 2021-02 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 252306 | 2021-05 | 2022-03 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 264439 | 2022-06 | 2023-04 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 268311 | 2022-11 | 2023-05 | Issued Notice of Compliance |
Dupilumab | Other dermatological preparations | 266537 | 2022-09 | 2023-07 | Issued Notice of Compliance |
Durvalumab | Antineoplastic agents | 233107 | 2019-11 | 2020-09 | Issued Notice of Compliance |
Durvalumab | Antineoplastic agents | 262782 | 2022-04 | 2022-09 | Issued Notice of Compliance |
Eculizumab | Immunosuppressants | 212987 | 2018-02 | 2018-08 | Issued Notice of Compliance |
Eculizumab | Immunosuppressants | 225847 | 2019-04 | 2019-09 | Issued Notice of Compliance |
ElasomeranTable 4 note de bas de page b |
Vaccines |
253430 |
2021-06 |
2021-08 |
|
Elasomeran | Vaccines | 257293 | 2021-10 | 2021-11 | Issued Notice of Compliance |
Elasomeran | Vaccines | 258658 | 2021-11 | 2022-03 | Issued Notice of Compliance |
Elasomeran | Vaccines | 263775 | 2022-04 | 2022-07 | Issued Notice of Compliance |
Elasomeran | Vaccines | 262952 | 2022-04 | 2022-09 | Cancelled by sponsor |
Elasomeran | Vaccines | 262408 | 2022-03 | 2022-12 | Issued Notice of Compliance |
Elasomeran, imelasomeran | Vaccines | 269428 | 2022-11 | 2023-02 | Issued Notice of Compliance |
Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 255136 | 2021-10 | 2022-04 | Issued Notice of Compliance |
Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 271750 | 2023-04 | 2023-10 | Issued Notice of Compliance |
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
282009 |
2024-01 |
2024-07 |
Issued Notice of Compliance |
Eltrombopag olamine | Antihemorrhagics | 195798 | 2016-07 | 2017-05 | Issued Notice of Compliance |
Eltrombopag olamine | Antihemorrhagics | 217802 | 2018-07 | 2019-05 | Issued Notice of Compliance |
Eltrombopag olamine | Antihemorrhagics | 216004 | 2018-06 | 2019-06 | Cancelled by sponsor |
Emicizumab | Antihemorrhagics | 222209 | 2018-12 | 2019-06 | Issued Notice of Compliance |
Empagliflozin | Drugs used in diabetes | 193840 | 2016-05 | 2018-04 | Issued Notice of Compliance |
Empagliflozin | Drugs used in diabetes | 221628 | 2019-01 | 2019-04 | Issued Notice of Compliance |
Empagliflozin | Drugs used in diabetes | 246457 | 2021-01 | 2021-10 | Issued Notice of Compliance |
Empagliflozin | Drugs used in diabetes | 256491 | 2021-10 | 2022-04 | Issued Notice of Compliance |
Empagliflozin | Drugs used in diabetes | 270652 | 2023-03 | 2024-01 | Issued Notice of Compliance |
Empagliflozin, linagliptin | Drugs used in diabetes | 204589 | 2017-06 | 2018-04 | Issued Notice of Compliance |
Emtricitabine, tenofovir alafenamide | Antivirals for systemic use | 234525 | 2020-02 | 2020-11 | Issued Notice of Compliance |
Enoxaparin sodium | Antithrombotic agents | 209807 | 2017-11 | 2018-09 | Issued Notice of Compliance |
Enzalutamide | Endocrine therapy | 216719 | 2018-06 | 2018-12 | Issued Notice of Compliance |
Enzalutamide | Endocrine therapy | 233563 | 2019-12 | 2020-06 | Issued Notice of Compliance |
Enzalutamide | Endocrine therapy | 277282 | 2023-08 | 2024-01 | Issued Notice of Compliance |
Eptacog alfa | Antihemorrhagics | 200866 | 2017-01 | 2017-11 | Issued Notice of Compliance |
Eptacog alfa | Antihemorrhagics | 267878 | 2022-11 | 2023-03 | Cancelled by sponsor |
Eribulin mesylate | Antineoplastic agents | 197739 | 2016-10 | 2017-08 | Issued Notice of Compliance |
Erlotinib hydrochloride | Antineoplastic agents | 194018 | 2016-06 | 2017-03 | Issued Notice of Compliance |
Esketamine hydrochloride | Psychoanaleptics | 244338 | 2020-11 | 2021-09 | Issued Notice of Compliance |
Eslicarbazepine acetate | Antiepileptics | 208086 | 2017-09 | 2018-06 | Issued Notice of Compliance |
Eslicarbazepine acetate | Antiepileptics | 209753 | 2017-11 | 2018-09 | Issued Notice of Compliance |
Etanercept | Immunosuppressants | 193787 | 2016-05 | 2017-03 | Issued Notice of Compliance |
Etanercept | Immunosuppressants | 213347 | 2018-03 | 2019-01 | Issued Notice of Compliance |
Etanercept | Immunosuppressants | 231313 | 2019-10 | 2020-08 | Issued Notice of Compliance |
Etanercept | Immunosuppressants | 226145 | 2019-05 | 2020-12 | Issued Notice of Compliance |
Everolimus | Antineoplastic agents | 200814 | 2017-01 | 2017-11 | Issued Notice of Compliance |
Evolocumab | Lipid modifying agents | 207038 | 2017-08 | 2018-06 | Issued Notice of Compliance |
Evolocumab | Lipid modifying agents | 208904 | 2017-10 | 2018-08 | Issued Notice of Compliance |
Evolocumab | Lipid modifying agents | 247936 | 2021-02 | 2021-12 | Issued Notice of Compliance |
Exenatide | Drugs used in diabetes | 208034 | 2017-09 | 2018-07 | Issued Notice of Compliance |
Famtozinameran, tozinameran | Vaccines | 268826 | 2022-10 | 2022-12 | Issued Notice of Compliance |
Famtozinameran, tozinameran | Vaccines | 274152 | 2023-03 | 2023-07 | Issued Notice of Compliance |
Famtozinameran, tozinameran | Vaccines | 275559 | 2023-06 | 2023-08 | Issued Notice of Compliance |
Faricimab |
Ophthalmologicals |
278042 |
2023-09 |
2024-07 |
Issued Notice of Compliance |
Fibrinogen (human) | Antihemorrhagics | 230407 | 2019-09 | 2020-07 | Issued Notice of Compliance |
Fibrinogen (human) | Antihemorrhagics | 227551 | 2019-06 | 2020-11 | Cancelled by sponsor |
Fingolimod hydrochloride | Immunosuppressants | 215423 | 2018-05 | 2018-11 | Issued Notice of Compliance |
Flibanserin | Other gynecologicals | 229727 | 2019-07 | 2021-01 | Issued Notice of Compliance |
Fluticasone furoate | Drugs for obstructive airway diseases | 208727 | 2017-10 | 2018-10 | Cancelled by sponsor |
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 215148 | 2018-05 | 2019-03 | Issued Notice of Compliance |
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 240101 | 2020-07 | 2021-05 | Issued Notice of Compliance |
Formoterol fumarate dihydrate, mometasone furoate | Drugs for obstructive airway diseases | 239493 | 2020-06 | 2021-04 | Issued Notice of Compliance |
Fosfomycin sodium | Antibacterials for systemic use | 256308 | 2021-12 | 2022-10 | Issued Notice of Compliance |
Fulvestrant | Endocrine therapy | 201150 | 2017-01 | 2017-11 | Issued Notice of Compliance |
Gadoterate meglumine | Contrast media | 205610 | 2017-06 | 2018-04 | Issued Notice of Compliance |
Gadoteridol | Contrast media | 252254 | 2021-07 | 2022-05 | Issued Notice of Compliance |
Galcanezumab | Analgesics | 232324 | 2019-11 | 2020-09 | Issued Notice of Compliance |
Glecaprevir, pibrentasvir | Antivirals for systemic use | 222816 | 2018-12 | 2019-06 | Issued Notice of Compliance |
Glecaprevir, pibrentasvir | Antivirals for systemic use | 247707 | 2021-02 | 2021-11 | Issued Notice of Compliance |
Glycerol phenylbutyrate | Other alimentary tract and metabolism products | 259175 | 2022-02 | 2022-11 | Issued Notice of Compliance |
Glycopyrronium bromide, indacaterol maleate | Drugs for obstructive airway diseases | 198552 | 2016-11 | 2017-08 | Issued Notice of Compliance |
Golimumab | Immunosuppressants | 197362 | 2016-09 | 2017-06 | Issued Notice of Compliance |
Golimumab | Immunosuppressants | 205724 | 2017-06 | 2018-04 | Issued Notice of Compliance |
Golimumab | Immunosuppressants | 255908 | 2021-10 | 2022-07 | Issued Notice of Compliance |
Goserelin acetate | Endocrine therapy | 275599 | 2023-07 | 2024-05 | Issued Notice of Compliance |
Guselkumab | Immunosuppressants | 232124 | 2019-11 | 2020-09 | Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | 199807 | 2016-11 | 2017-05 | Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 225528 | 2019-04 | 2020-02 | Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 229325 | 2019-08 | 2020-06 | Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 238479 | 2020-05 | 2021-03 | Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 246936 | 2021-01 | 2021-11 | Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 251147 | 2021-05 | 2022-03 | Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) | Vaccines | 218188 | 2018-08 | 2019-06 | Cancelled by sponsor |
Hexaminolevulinate hydrochloride | Diagnostic agents | 273436 | 2023-05 | 2024-03 | Issued Notice of Compliance |
Human immunoglobulin | Immune sera and immunoglobulins | 208033 | 2017-09 | 2018-07 | Issued Notice of Compliance |
Hyaluronidase (human recombinant), immunoglobulin (human) | Immune sera and immunoglobulins | 276884 | 2023-08 | 2024-06 | Issued Notice of Compliance |
Hydromorphone hydrochloride | Analgesics | 223245 | 2019-01 | 2019-05 | Issued Notice of Compliance |
Hydroxyethyl starch | Blood substitutes and perfusion solutions | 222938 | 2019-04 | 2020-02 | Issued Notice of Compliance |
Hydroxyethyl starch | Blood substitutes and perfusion solutions | 223031 | 2019-04 | 2020-02 | Issued Notice of Compliance |
Hydroxyurea | Antineoplastic agents | 226144 | 2019-04 | 2020-02 | Issued Notice of Compliance |
Ibrutinib | Immunosuppressants | 204436 | 2017-05 | 2017-10 | Issued Notice of Compliance |
Ibrutinib | Antineoplastic agents | 212632 | 2018-02 | 2018-07 | Issued Notice of Compliance |
Ibrutinib | Antineoplastic agents | 218457 | 2018-08 | 2019-02 | Issued Notice of Compliance |
Ibrutinib | Antineoplastic agents | 222804 | 2019-01 | 2019-11 | Issued Notice of Compliance |
Ibrutinib | Antineoplastic agents | 235706 | 2020-02 | 2020-12 | Issued Notice of Compliance |
Ibrutinib | Antineoplastic agents | 263702 | 2022-05 | 2023-03 | Issued Notice of Compliance |
Ibrutinib | Antineoplastic agents | 266710 | 2022-10 | 2023-08 | Issued Notice of Compliance |
Icatibant acetate | Other hematological agents | 217805 | 2018-09 | 2019-06 | Issued Notice of Compliance |
Idelalisib | Antineoplastic agents | 203513 | 2017-04 | 2017-12 | Cancelled by sponsor |
Immunoglobulin (human) | Immune sera and immunoglobulins | 201326 | 2017-01 | 2017-10 | Issued Notice of Compliance |
Immunoglobulin (human) | Immune sera and immunoglobulins | 223557 | 2019-02 | 2019-11 | Cancelled by sponsor |
Immunoglobulin (human) | Immune sera and immunoglobulins | 240691 | 2020-07 | 2021-05 | Issued Notice of Compliance |
Immunoglobulin (human) | Immune sera and immunoglobulins | 253256 | 2021-07 | 2022-05 | Issued Notice of Compliance |
IncobotulinumtoxinA | Muscle relaxants | 208713 | 2017-10 | 2019-06 | Issued Notice of Compliance |
IncobotulinumtoxinA | Muscle relaxants | 234438 | 2020-01 | 2020-11 | Issued Notice of Compliance |
IncobotulinumtoxinA | Muscle relaxants | 251521 | 2021-05 | 2022-03 | Issued Notice of Compliance |
IncobotulinumtoxinA | Muscle relaxants | 257192 | 2021-11 | 2022-09 | Issued Notice of Compliance |
IncobotulinumtoxinA | Muscle relaxants | 268590 | 2022-11 | 2023-10 | Cancelled by sponsor |
Infliximab | Immunosuppressants | 220321 | 2018-11 | 2019-08 | Issued Notice of Compliance |
Infliximab | Immunosuppressants | 262141 | 2022-04 | 2023-03 | Issued Notice of Compliance |
Infliximab | Immunosuppressants | 272981 | 2023-04 | 2024-02 | Issued Notice of Compliance |
Insulin aspart | Drugs used in diabetes | 226586 | 2019-05 | 2020-02 | Issued Notice of Compliance |
Insulin aspart | Drugs used in diabetes | 254352 | 2021-10 | 2022-07 | Issued Notice of Compliance |
Insulin degludec | Drugs used in diabetes | 208917 | 2017-10 | 2018-07 | Issued Notice of Compliance |
Insulin degludec, liraglutide | Drugs used in diabetes | 234406 | 2020-01 | 2020-11 | Issued Notice of Compliance |
Insulin glargine | Drugs used in diabetes | 228382 | 2019-07 | 2020-05 | Issued Notice of Compliance |
Insulin glargine, lixisenatide | Drugs used in diabetes | 232504 | 2019-11 | 2020-09 | Issued Notice of Compliance |
Iohexol | Contrast media | 268527 | 2023-03 | 2023-12 | Issued Notice of Compliance |
Ipilimumab | Antineoplastic agents | 202533 | 2017-02 | 2017-04 | Issued Notice of Compliance |
Ipilimumab | Antineoplastic agents | 255450 | 2021-09 | 2022-03 | Issued Notice of Compliance |
Ipilimumab | Antineoplastic agents | 270801 | 2023-02 | 2023-12 | Issued Notice of Compliance |
Isatuximab | Antineoplastic agents | 244601 | 2020-10 | 2021-09 | Issued Notice of Compliance |
Ivacaftor | Other respiratory system products | 218044 | 2018-08 | 2019-01 | Issued Notice of Compliance |
Ivacaftor | Other respiratory system products | 247481 | 2021-02 | 2021-08 | Issued Notice of Compliance |
Ivacaftor | Other respiratory system products | 255781 | 2021-09 | 2022-03 | Issued Notice of Compliance |
Ivacaftor | Other respiratory system products | 273575 | 2023-06 | 2023-11 | Issued Notice of Compliance |
Ivacaftor, lumacaftor | Other respiratory system products | 198036 | 2016-10 | 2017-04 | Issued Notice of Compliance |
Ivacaftor, lumacaftor | Other respiratory system products | 215032 | 2018-06 | 2018-12 | Issued Notice of Compliance |
Ivacaftor, lumacaftor | Other respiratory system products | 264825 | 2022-07 | 2023-04 | Issued Notice of Compliance |
Ixekizumab | Immunosuppressants | 204690 | 2017-06 | 2018-03 | Issued Notice of Compliance |
Ixekizumab | Immunosuppressants | 225178 | 2019-04 | 2020-02 | Issued Notice of Compliance |
Ixekizumab | Immunosuppressants | 233071 | 2019-12 | 2020-10 | Issued Notice of Compliance |
Ixekizumab | Immunosuppressants | 238580 | 2020-06 | 2021-03 | Issued Notice of Compliance |
Japanese encephalitis virus vaccine inactivated | Vaccines | 203520 | 2017-05 | 2018-03 | Issued Notice of Compliance |
Lacosamide | Antiepileptics | 193732 | 2016-05 | 2017-02 | Issued Notice of Compliance |
Lanreotide acetate | Pituitary and hypothalamic hormones and analogues | 203094 | 2017-04 | 2018-02 | Issued Notice of Compliance |
Ledipasvir, sofosbuvir | Antivirals for systemic use | 199607 | 2016-11 | 2017-05 | Issued Notice of Compliance |
Lenvatinib mesylate | Antineoplastic agents | 197794 | 2016-11 | 2017-09 | Issued Notice of Compliance |
Lenvatinib mesylate | Antineoplastic agents | 212989 | 2018-02 | 2018-12 | Issued Notice of Compliance |
Lenvatinib mesylate | Antineoplastic agents | 228723 | 2019-07 | 2019-09 | Issued Notice of Compliance under the NOC/c Guidance |
Lenvatinib mesylate | Antineoplastic agents | 252195 | 2021-06 | 2022-02 | Cancelled by sponsor |
Lenvatinib mesylate | Antineoplastic agents | 253057 | 2021-07 | 2022-05 | Issued Notice of Compliance |
Letermovir | Antivirals for systemic use | 272553 | 2023-03 | 2023-09 | Issued Notice of Compliance |
Leucovorin calcium | All other therapeutic products | 276242 | 2023-08 | 2023-12 | Issued Notice of Compliance |
Leuprolide acetate | Endocrine therapy | 193372 | 2016-05 | 2017-02 | Issued Notice of Compliance |
Leuprolide acetate | Endocrine therapy | 269016 | 2022-12 | 2023-09 | Issued Notice of Compliance |
Leuprolide acetate | Endocrine therapy | 254192 | 2021-10 | 2024-01 | Issued Notice of Compliance |
Levomilnacipran | Psychoanaleptics | 222857 | 2019-01 | 2019-11 | Issued Notice of Compliance |
Levonorgestrel | Sex hormones and modulators of the genital system | 204355 | 2017-05 | 2018-03 | Issued Notice of Compliance |
Levonorgestrel | Other gynecologicals | 273103 | 2023-04 | 2024-02 | Issued Notice of Compliance |
Linagliptin | Drugs used in diabetes | 194075 | 2016-06 | 2018-10 | Issued Notice of Compliance |
Linagliptin | Drugs used in diabetes | 222572 | 2019-01 | 2019-11 | Issued Notice of Compliance |
Linagliptin, metformin hydrochloride | Drugs used in diabetes | 194067 | 2016-06 | 2017-05 | Cancelled by sponsor |
Linagliptin, metformin hydrochloride | Drugs used in diabetes | 229225 | 2019-08 | 2020-06 | Issued Notice of Compliance |
Liraglutide | Drugs used in diabetes | 196457 | 2016-08 | 2017-06 | Issued Notice of Compliance |
Liraglutide | Drugs used in diabetes | 200821 | 2017-01 | 2017-11 | Issued Notice of Compliance |
Liraglutide | Drugs used in diabetes | 225809 | 2019-05 | 2020-02 | Issued Notice of Compliance |
Liraglutide | Drugs used in diabetes | 237880 | 2020-05 | 2021-02 | Issued Notice of Compliance |
Lorlatinib | Antineoplastic agents | 247174 | 2021-01 | 2021-06 | Issued Notice of Compliance |
Lumasiran sodium | Other alimentary tract and metabolism products | 265088 | 2022-07 | 2023-05 | Issued Notice of Compliance |
Lurasidone hydrochloride | Psycholeptics | 197342 | 2016-09 | 2017-07 | Issued Notice of Compliance |
Lurasidone hydrochloride | Psycholeptics | 205325 | 2017-06 | 2018-04 | Issued Notice of Compliance |
Macitentan | Antihypertensives | 219599 | 2018-11 | 2019-11 | Cancelled by sponsor |
Macitentan | Antihypertensives | 221389 | 2019-01 | 2020-07 | Issued Notice of Compliance |
Mavacamten | Cardiac therapy | 272517 | 2023-04 | 2024-02 | Issued Notice of Compliance |
Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid | Vaccines | 203844 | 2017-04 | 2018-02 | Issued Notice of Compliance |
Mepolizumab | Drugs for obstructive airway diseases | 208467 | 2017-09 | 2018-07 | Issued Notice of Compliance |
Mepolizumab | Drugs for obstructive airway diseases | 212242 | 2018-02 | 2018-10 | Cancelled by sponsor |
Mepolizumab | Drugs for obstructive airway diseases | 221528 | 2018-12 | 2019-10 | Issued Notice of Compliance |
Mepolizumab | Drugs for obstructive airway diseases | 226197 | 2019-05 | 2020-03 | Issued Notice of Compliance |
Mepolizumab | Drugs for obstructive airway diseases | 247542 | 2021-01 | 2021-11 | Issued Notice of Compliance |
Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 255153 | 2021-09 | 2022-08 | Issued Notice of Compliance |
Methyl aminolevulinate hydrochloride | Antineoplastic agents | 262828 | 2022-04 | 2023-02 | Issued Notice of Compliance |
Methylphenidate hydrochloride | Psychoanaleptics | 214860 | 2018-05 | 2019-03 | Issued Notice of Compliance |
Methylphenidate hydrochloride | Psychoanaleptics | 224342 | 2019-03 | 2020-01 | Issued Notice of Compliance |
Midostaurin | Antineoplastic agents | 210496 | 2017-12 | 2018-10 | Issued Notice of Compliance |
Mifepristone, misoprostol | Sex hormones and modulators of the genital system | 200856 | 2017-01 | 2017-11 | Issued Notice of Compliance |
Migalastat hydrochloride | Other alimentary tract and metabolism products | 262810 | 2022-05 | 2023-03 | Issued Notice of Compliance |
Nadroparin calcium | Antithrombotic agents | 195973 | 2016-08 | 2017-07 | Issued Notice of Compliance |
Naloxegol oxalate | Drugs for constipation | 221031 | 2018-11 | 2019-09 | Cancelled by sponsor |
Neratinib maleate | Antineoplastic agents | 242449 | 2020-09 | 2021-06 | Issued Notice of Compliance |
Nilotinib | Antineoplastic agents | 211052 | 2017-12 | 2018-10 | Issued Notice of Compliance |
Nintedanib | Antineoplastic agents | 227166 | 2019-05 | 2019-11 | Issued Notice of Compliance |
Nintedanib | Antineoplastic agents | 232923 | 2019-11 | 2020-05 | Issued Notice of Compliance |
Nintedanib | Antineoplastic agents | 241747 | 2020-08 | 2021-06 | Issued Notice of Compliance |
Niraparib | Antineoplastic agents | 237670 | 2020-04 | 2020-10 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 199379 | 2016-11 | 2017-05 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 203286 | 2017-03 | 2017-11 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 203593 | 2017-04 | 2018-01 | Cancelled by sponsor |
Nivolumab | Antineoplastic agents | 206974 | 2017-07 | 2018-03 | Issued Notice of Compliance under the NOC/c Guidance |
Nivolumab | Antineoplastic agents | 212067 | 2018-01 | 2018-07 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 211838 | 2018-01 | 2018-11 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 215535 | 2018-06 | 2019-11 | Cancelled by sponsor |
Nivolumab | Antineoplastic agents | 236255 | 2020-03 | 2020-08 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 234228 | 2020-01 | 2020-11 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 239474 | 2020-06 | 2021-02 | Issued Notice of Compliance under the NOC/c Guidance |
Nivolumab | Antineoplastic agents | 243600 | 2020-09 | 2021-05 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 247045 | 2021-01 | 2021-07 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 245851 | 2020-12 | 2021-10 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 247339 | 2021-01 | 2021-10 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 253652 | 2021-07 | 2022-06 | Issued Notice of Compliance under the NOC/c Guidance |
Nivolumab | Antineoplastic agents | 257103 | 2021-11 | 2022-07 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 261300 | 2022-03 | 2022-08 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 272504 | 2023-03 | 2023-12 | Issued Notice of Compliance |
Nivolumab | Antineoplastic agents | 282374 | 2024-01 | 2024-06 | Issued Notice of Compliance |
Norfloxacin | Antibacterials for systemic use | 208906 | 2017-10 | 2017-12 | Issued Notice of Compliance |
Obinutuzumab | Antineoplastic agents | 208089 | 2017-09 | 2018-07 | Issued Notice of Compliance |
Olaparib | Antineoplastic agents | 210204 | 2017-11 | 2018-05 | Issued Notice of Compliance |
Olaparib | Antineoplastic agents | 219799 | 2018-11 | 2019-05 | Issued Notice of Compliance |
Olaparib | Antineoplastic agents | 230309 | 2019-08 | 2020-02 | Issued Notice of Compliance |
Olaparib | Antineoplastic agents | 235698 | 2020-02 | 2020-08 | Issued Notice of Compliance |
Olaparib | Antineoplastic agents | 259417 | 2022-01 | 2022-07 | Issued Notice of Compliance under the NOC/c Guidance |
Olaparib | Antineoplastic agents | 265427 | 2022-08 | 2023-07 | Issued Notice of Compliance under the NOC/c Guidance |
Olodaterol hydrochloride, tiotropium bromide monohydrate | Drugs for obstructive airway diseases | 223910 | 2019-03 | 2019-12 | Issued Notice of Compliance |
Omalizumab | Drugs for obstructive airway diseases | 194542 | 2016-06 | 2017-04 | Issued Notice of Compliance |
Omalizumab | Drugs for obstructive airway diseases | 241064 | 2020-08 | 2021-07 | Issued Notice of Compliance |
Ombitasvir, paritaprevir, ritonavir | Antivirals for systemic use | 195504 | 2016-07 | 2017-05 | Issued Notice of Compliance |
OnabotulinumtoxinA | Muscle relaxants | 211053 | 2017-12 | 2018-10 | Issued Notice of Compliance |
OnabotulinumtoxinA | Muscle relaxants | 237685 | 2020-05 | 2021-03 | Issued Notice of Compliance |
OnabotulinumtoxinA | Muscle relaxants | 273166 | 2023-04 | 2024-02 | Issued Notice of Compliance |
OnabotulinumtoxinA | Muscle relaxants | 275576 | 2023-06 | 2024-04 | Cancelled by sponsor |
Osimertinib mesylate | Antineoplastic agents | 211762 | 2018-01 | 2018-07 | Issued Notice of Compliance |
Osimertinib mesylate | Antineoplastic agents | 243288 | 2020-09 | 2021-01 | Issued Notice of Compliance |
Osimertinib mesylate |
Antineoplastic agents |
279138 |
2023-10 |
2024-07 |
Issued Notice of Compliance |
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 | 209413 | 2017-11 | 2018-08 | Issued Notice of Compliance |
Ozanimod | Immunosuppressants | 248992 | 2021-05 | 2022-04 | Issued Notice of Compliance |
Palbociclib | Antineoplastic agents | 195948 | 2016-07 | 2017-05 | Issued Notice of Compliance |
Palbociclib | Antineoplastic agents | 219500 | 2018-10 | 2019-08 | Issued Notice of Compliance |
Palbociclib | Antineoplastic agents | 273901 | 2023-05 | 2024-03 | Issued Notice of Compliance |
Palonosetron hydrochloride | Antiemetics and antinauseants | 215829 | 2018-06 | 2019-04 | Issued Notice of Compliance |
Panitumumab | Antineoplastic agents | 193962 | 2016-06 | 2017-04 | Issued Notice of Compliance |
Pasireotide | Pituitary and hypothalamic hormones and analogues | 209345 | 2017-11 | 2018-08 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 201200 | 2017-01 | 2017-09 | Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab | Antineoplastic agents | 203157 | 2017-03 | 2017-09 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 212388 | 2018-01 | 2018-09 | Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab | Antineoplastic agents | 215699 | 2018-05 | 2019-03 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 209011 | 2017-09 | 2019-04 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 216451 | 2018-06 | 2019-04 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 218779 | 2018-08 | 2019-04 | Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab | Antineoplastic agents | 219700 | 2018-10 | 2019-07 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 228721 | 2019-07 | 2019-09 | Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab | Antineoplastic agents | 223819 | 2019-02 | 2019-12 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 219213 | 2018-09 | 2020-03 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 232775 | 2019-12 | 2020-10 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 236910 | 2020-04 | 2020-12 | Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab | Antineoplastic agents | 239505 | 2020-06 | 2021-02 | Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab | Antineoplastic agents | 240864 | 2020-07 | 2021-03 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 246922 | 2020-12 | 2021-06 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 246373 | 2020-12 | 2021-11 | Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab | Antineoplastic agents | 252263 | 2021-06 | 2022-02 | Cancelled by sponsor |
Pembrolizumab | Antineoplastic agents | 256659 | 2021-10 | 2022-04 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 257236 | 2021-11 | 2022-04 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 253060 | 2021-07 | 2022-05 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 259703 | 2022-01 | 2022-07 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 256537 | 2021-10 | 2022-08 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 264318 | 2022-06 | 2023-04 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 272409 | 2023-03 | 2024-02 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 273487 | 2023-05 | 2024-03 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 275053 | 2023-06 | 2024-04 | Issued Notice of Compliance |
Pembrolizumab | Antineoplastic agents | 276501 | 2023-08 | 2024-05 | Issued Notice of Compliance |
Perampanel | Antiepileptics | 204327 | 2017-05 | 2018-03 | Issued Notice of Compliance |
Perampanel | Antiepileptics | 225719 | 2019-05 | 2020-02 | Issued Notice of Compliance |
Pertuzumab | Antineoplastic agents | 209467 | 2017-11 | 2018-08 | Issued Notice of Compliance |
Pertuzumab, trastuzumab | Antineoplastic agents | 222022 | 2018-12 | 2020-07 | Issued Notice of Compliance |
Pertuzumab, trastuzumab | Antineoplastic agents | 230602 | 2019-09 | 2021-02 | Issued Notice of Compliance |
Pertuzumab, trastuzumab | Antineoplastic agents | 254251 | 2021-07 | 2022-01 | Issued Notice of Compliance |
Pimecrolimus | Other dermatological preparations | 220947 | 2018-11 | 2019-09 | Issued Notice of Compliance |
Pimecrolimus | Other dermatological preparations | 247851 | 2021-01 | 2023-09 | Cancelled by sponsor |
Pitolisant hydrochloride | Other nervous system drugs | 270856 | 2023-02 | 2024-01 | Issued Notice of Compliance |
Plerixafor | Immunostimulants | 213345 | 2018-03 | 2019-01 | Issued Notice of Compliance |
Polatuzumab vedotin | Antineoplastic agents | 259726 | 2022-01 | 2022-11 | Issued Notice of Compliance |
Pomalidomide | Immunosuppressants | 218459 | 2018-09 | 2019-07 | Issued Notice of Compliance |
Ranibizumab | Ophthalmologicals | 201272 | 2017-01 | 2017-11 | Issued Notice of Compliance |
Ranibizumab | Opthalmologicals | 233361 | 2019-11 | 2021-11 | Issued Notice of Compliance under the NOC/c Guidance |
Ravulizumab | Immunosuppressants | 259173 | 2022-01 | 2022-11 | Issued Notice of Compliance |
Ravulizumab | Immunosuppressants | 261864 | 2022-03 | 2023-01 | Issued Notice of Compliance |
Ravulizumab | Immunosuppressants | 269852 | 2023-01 | 2023-10 | Issued Notice of Compliance |
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | 223244 | 2019-02 | 2020-08 | Issued Notice of Compliance |
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein | Vaccines | 251509 | 2021-05 | 2022-04 | Issued Notice of Compliance under the NOC/c Guidance |
Regorafenib | Antineoplastic agents | 203322 | 2017-04 | 2017-09 | Issued Notice of Compliance |
Remdesivir | Antivirals for systemic use | 250151 | 2021-04 | 2022-04 | Issued Notice of Compliance |
Remdesivir | Antivirals for systemic use | 266313 | 2022-08 | 2023-06 | Issued Notice of Compliance |
Ribociclib succinate | Antineoplastic agents | 225074 | 2019-04 | 2020-02 | Issued Notice of Compliance |
Ribociclib succinate | Antineoplastic agents | 233623 | 2019-12 | 2020-10 | Issued Notice of Compliance |
Ribociclib succinate | Antineoplastic agents | 262779 | 2022-04 | 2023-02 | Issued Notice of Compliance |
Rifaximin | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 209230 | 2018-02 | 2018-12 | Issued Notice of Compliance |
Risankizumab | Immunosuppressants | 251455 | 2021-05 | 2022-03 | Issued Notice of Compliance |
Risankizumab | Immunosuppressants | 258394 | 2021-12 | 2022-10 | Issued Notice of Compliance |
Rituximab | Antineoplastic agents | 204718 | 2017-05 | 2018-03 | Issued Notice of Compliance |
Rituximab | Antineoplastic agents | 228130 | 2019-07 | 2020-05 | Issued Notice of Compliance |
Rituximab | Antineoplastic agents | 242572 | 2020-09 | 2021-06 | Issued Notice of Compliance |
Rivaroxaban | Antithrombotic agents | 211611 | 2018-01 | 2018-09 | Issued Notice of Compliance |
Rivaroxaban | Antithrombotic agents | 233166 | 2020-02 | 2020-11 | Issued Notice of Compliance |
Rivaroxaban | Antithrombotic agents | 234756 | 2020-03 | 2021-01 | Issued Notice of Compliance |
Romiplostim | Antihemorrhagics | 243699 | 2020-10 | 2021-08 | Issued Notice of Compliance |
Romosozumab | Drugs for treatment of bone diseases | 262756 | 2022-05 | 2023-03 | Cancelled by sponsor |
Rufinamide | Antiepileptics | 194343 | 2016-06 | 2017-04 | Issued Notice of Compliance |
Ruxolitinib phosphate | Antineoplastic agents | 250022 | 2021-03 | 2022-05 | Issued Notice of Compliance |
Sacituzumab govitecan | Antineoplastic agents | 270849 | 2023-01 | 2023-07 | Issued Notice of Compliance |
Sarilumab | Immunosuppressants | 211993 | 2018-01 | 2019-08 | Issued Notice of Compliance |
SARS-CoV-2 recombinant spike protein | Vaccines | 266285 | 2022-07 | 2022-11 | Issued Notice of Compliance |
SARS-CoV-2 recombinant spike protein | Vaccines | 265342 | 2022-06 | 2022-12 | Issued Notice of Compliance |
SARS-CoV-2 recombinant spike protein | Vaccines | 273313 | 2023-03 | 2023-11 | Cancelled by sponsor |
Secukinumab | Immunosuppressants | 219231 | 2018-09 | 2019-07 | Issued Notice of Compliance |
Secukinumab | Immunosuppressants | 235994 | 2020-03 | 2021-01 | Issued Notice of Compliance |
Secukinumab | Immunosuppressants | 240496 | 2020-07 | 2021-05 | Issued Notice of Compliance |
Secukinumab | Immunosuppressants | 250272 | 2021-05 | 2022-03 | Issued Notice of Compliance |
Secukinumab | Immunosuppressants | 257230 | 2021-11 | 2022-09 | Issued Notice of Compliance |
Secukinumab | Immunosuppressants | 269287 | 2022-12 | 2024-05 | Issued Notice of Compliance |
Semaglutide | Drugs used in diabetes | 227387 | 2019-06 | 2020-03 | Cancelled by sponsor |
Semaglutide | Drugs used in diabetes | 231580 | 2019-10 | 2020-08 | Issued Notice of Compliance |
Semaglutide | Drugs used in diabetes | 245932 | 2020-12 | 2021-10 | Issued Notice of Compliance |
Semaglutide | Drugs used in diabetes | 266244 | 2022-09 | 2023-06 | Issued Notice of Compliance |
Sevelamer carbonate | All other therapeutic products | 211598 | 2018-04 | 2019-02 | Issued Notice of Compliance |
Simeprevir | Antivirals for systemic use | 197253 | 2016-09 | 2017-07 | Issued Notice of Compliance |
Sofosbuvir, velpatasvir | Antivirals for systemic use | 199753 | 2016-12 | 2017-09 | Issued Notice of Compliance |
Sofosbuvir, velpatasvir | Antivirals for systemic use | 233923 | 2020-01 | 2020-11 | Issued Notice of Compliance |
Somatropin | Pituitary and hypothalamic hormones and analogues | 205985 | 2017-06 | 2018-04 | Issued Notice of Compliance |
Somatropin | Pituitary and hypothalamic hormones and analogues | 241147 | 2020-08 | 2021-06 | Issued Notice of Compliance |
Somatropin R-DNA origin | Pituitary and hypothalamic hormones and analogues | 229726 | 2019-08 | 2020-06 | Issued Notice of Compliance |
Spesolimab |
Immunosuppressants |
278317 |
2023-10 |
2024-07 |
Issued Notice of Compliance |
Standardized short ragweed pollen allergenic extract | Allergens | 234565 | 2020-02 | 2020-12 | Issued Notice of Compliance |
Sugammadex | All other therapeutic products | 234372 | 2020-01 | 2021-10 | Issued Notice of Compliance |
Sulfur hexafluoride | Contrast media | 231944 | 2019-11 | 2020-08 | Issued Notice of Compliance |
Sunitinib malate | Antineoplastic agents | 208710 | 2017-10 | 2019-04 | Issued Notice of Non-compliance- Withdrawal |
Teduglutide | Other alimentary tract and metabolism products | 223862 | 2019-02 | 2019-08 | Issued Notice of Compliance |
Teriflunomide | Immunosuppressants | 231739 | 2019-11 | 2020-09 | Issued Notice of Compliance |
Thioguanine | Antineoplastic agents | 199259 | 2016-11 | 2017-09 | Issued Notice of Compliance |
Ticagrelor | Antithrombotic agents | 231818 | 2019-10 | 2020-08 | Issued Notice of Compliance |
Tinzaparin sodium | Antithrombotic agents | 199839 | 2016-12 | 2018-11 | Cancelled by sponsor |
Tipiracil hydrochloride, trifluridine | Antineoplastic agents | 227070 | 2019-05 | 2019-11 | Issued Notice of Compliance |
Tisagenlecleucel | Antineoplastic agents | 263500 | 2022-05 | 2022-12 | Issued Notice of Compliance under the NOC/c Guidance |
Tocilizumab | Immunosuppressants | 204251 | 2017-05 | 2017-10 | Issued Notice of Compliance |
Tocilizumab | Immunosuppressants | 219690 | 2018-10 | 2019-07 | Issued Notice of Compliance |
Tocilizumab | Immunosuppressants | 220039 | 2018-10 | 2019-08 | Issued Notice of Compliance |
Tocilizumab | Immunosuppressants | 261220 | 2022-02 | 2022-10 | Issued Notice of Compliance |
Tofacitinib | Immunosuppressants | 209522 | 2017-11 | 2018-09 | Issued Notice of Compliance |
Tofacitinib | Immunosuppressants | 209643 | 2017-12 | 2018-10 | Issued Notice of Compliance |
Tofacitinib | Immunosuppressants | 213578 | 2018-04 | 2019-01 | Issued Notice of Compliance |
Tofacitinib citrate | Immunosuppressants | 264582 | 2022-07 | 2023-05 | Issued Notice of Compliance |
Tofacitinib citrate | Immunosuppressants | 271059 | 2023-03 | 2024-04 | Issued Notice of Compliance |
Tolvaptan | Diuretics | 213262 | 2018-03 | 2019-01 | Issued Notice of Compliance |
TozinameranTable 4 note de bas de page b |
Vaccines |
251730 |
2021-04 |
2021-05 |
|
Tozinameran | Vaccines | 257162 | 2021-10 | 2021-11 | Issued Notice of Compliance |
Tozinameran | Vaccines | 257698 | 2021-10 | 2021-11 | Issued Notice of Compliance |
Tozinameran | Vaccines | 261729 | 2022-02 | 2022-06 | Issued Notice of Compliance |
Tozinameran | Vaccines | 264621 | 2022-05 | 2022-08 | Issued Notice of Compliance |
Tozinameran | Vaccines | 265483 | 2022-06 | 2022-09 | Issued Notice of Compliance |
Tralokinumab | Other dermatological preparations | 261661 | 2022-04 | 2023-02 | Issued Notice of Compliance |
Trametinib | Antineoplastic agents | 199382 | 2016-11 | 2017-05 | Issued Notice of Compliance |
Trametinib | Antineoplastic agents | 210760 | 2017-11 | 2018-05 | Issued Notice of Compliance |
Trametinib | Antineoplastic agents | 213580 | 2018-03 | 2018-09 | Issued Notice of Compliance |
Trametinib | Antineoplastic agents | 270386 | 2023-01 | 2023-07 | Issued Notice of Compliance |
Trastuzumab | Antineoplastic agents | 239083 | 2020-06 | 2021-04 | Issued Notice of Compliance |
Trastuzumab | Antineoplastic agents | 237674 | 2020-05 | 2021-04 | Issued Notice of Compliance |
Trastuzumab | Antineoplastic agents | 242479 | 2020-09 | 2021-04 | Issued Notice of Compliance |
Trastuzumab | Antineoplastic agents | 247842 | 2021-02 | 2021-12 | Issued Notice of Compliance |
Trastuzumab deruxtecan | Antineoplastic agents | 259440 | 2022-01 | 2022-06 | Issued Notice of Compliance |
Trastuzumab deruxtecan | Antineoplastic agents | 265333 | 2022-07 | 2023-01 | Issued Notice of Compliance |
Trastuzumab emtansine | Antineoplastic agents | 227372 | 2019-05 | 2019-11 | Issued Notice of Compliance |
Tretinoin | Anti-acne preparations | 235656 | 2020-03 | 2021-01 | Issued Notice of Compliance |
Umeclidinium bromide | Drugs for obstructive airway diseases | 222505 | 2019-01 | 2020-09 | Issued Notice of Compliance |
Upadacitinib | Immunosuppressants | 241253 | 2020-08 | 2021-06 | Issued Notice of Compliance |
Upadacitinib | Immunosuppressants | 245530 | 2020-12 | 2021-10 | Issued Notice of Compliance |
Upadacitinib | Immunosuppressants | 247702 | 2021-02 | 2022-07 | Issued Notice of Compliance |
Upadacitinib | Immunosuppressants | 264612 | 2022-07 | 2023-05 | Issued Notice of Compliance |
Upadacitinib | Immunosuppressants | 257284 | 2021-12 | 2023-07 | Issued Notice of Compliance |
Upadacitinib | Immunosuppressants | 267554 | 2022-12 | 2023-10 | Issued Notice of Compliance |
Ustekinumab | Immunosuppressants | 224739 | 2019-03 | 2020-01 | Issued Notice of Compliance |
Ustekinumab | Immunosuppressants | 230279 | 2019-08 | 2020-06 | Issued Notice of Compliance |
Varicella-zoster virus glycoprotein E (GE) | Vaccines | 246933 | 2021-01 | 2021-11 | Issued Notice of Compliance |
Venetoclax | Antineoplastic agents | 214078 | 2018-03 | 2018-09 | Issued Notice of Compliance |
Venetoclax | Antineoplastic agents | 228475 | 2019-07 | 2020-04 | Issued Notice of Compliance |
Venetoclax | Antineoplastic agents | 240541 | 2020-06 | 2021-01 | Issued Notice of Compliance |
Vilazodone hydrochloride | Psychoanaleptics | 210066 | 2017-11 | 2018-10 | Cancelled by sponsor |
Virus-like particles (VLP) of SARS-CoV-2 spike protein | Vaccines | 267448 | 2022-08 | 2023-03 | Issued Notice of Compliance |
Zanubrutinib | Antineoplastic agents | 254556 | 2021-09 | 2022-02 | Issued Notice of Compliance |
Zanubrutinib | Antineoplastic agents | 264963 | 2022-07 | 2023-05 | Issued Notice of Compliance |
Zanubrutinib | Antineoplastic agents | 273215 | 2023-04 | 2024-02 | Issued Notice of Compliance |
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