Generic submissions under review

How to access a list of generic drug submissions currently under review.

Consult the Drug and vaccine authorizations for COVID-19: List of applications received to access submissions under review that are related to the COVID-19 pandemic.

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About the Generic Submissions Under Review (GSUR) List

The Generic Submissions Under Review (GSUR) List helps to make our review processes more transparent. The list will help Canadians understand if generic versions of brand name drugs are currently under review in Canada.

The GSUR List was announced as part of Phase III of the Submissions Under Review (SUR) List initiative.

The GSUR List includes abbreviated new drug submissions (ANDSs) accepted into review on or after October 1, 2018.

Finding information on the list

The GSUR List entries each include the:

The list is updated monthly.

Decisions

The number of ANDSs under review with Health Canada in any given month changes depending on

  • ANDSs that are newly accepted for review
  • ANDSs that are cancelled by the sponsor (company)
  • Final decisions that are made on ANDSs (positive or negative)

You can see if a submission has been approved in the Notice of Compliance Database.

Health Canada announced in August 2018 that it will publish regulatory decision summaries for final positive and negative decisions for certain prescription generic drug submissions that might be of interest to stakeholders. These can be found using the Regulatory Decision Summary search tool in the Drug and Health Product Register.

Access to generic drugs

Many factors affect Canadians' access to generic drugs. For more information about generic drug products and submissions, please see the Fact Sheet on Access to Generic Drugs in Canada.

External consultations

Health Canada is now seeking feedback on the possible impacts and uses to stakeholders of adding sponsor (company) names to the Generic Submissions Under Review List.

Several external consultations have been held as the SUR List initiative has evolved. In 2017, an external consultation was held on five transparency proposals for prescription drugs. This report provides a summary of the consultation results.

Other lists of submissions under review

The Submissions Under Review (SUR) Lists include new drug submissions and supplemental new drug submissions for new uses. Click here for details and to access the Drug and health products submissions under review lists.

View the list

You can view the generic submissions under review list any time.

Generic submissions currently under review: Abbreviated new drug submissions
Medicinal Ingredient(s) Therapeutic Area Number of submissions under review
Abacavir sulfate, dolutegravir sodium, lamivudine Antivirals for systemic use 1
Abiraterone acetate Endocrine therapy 2
Acetylcysteine Cough and cold preparations 1
Acyclovir Antivirals for systemic use 2
Afatinib Antineoplastic agents 1
Afatinib dimaleate Antineoplastic agents 3
Alendronic acid, vitamin D3 Drugs for treatment of bone diseases 1
Alfacalcidol Vitamins 1
Ambrisentan Antihypertensives 2
Amikacin sulfate Antibacterials for systemic use 1
Amiodarone hydrochloride Cardiac therapy 1
Amlodipine besylate Calcium channel blockers 1
Amoxicillin trihydrate, clavulanic acid Antibacterials for systemic use 1
Anastrozole Endocrine therapy 1
Apixaban Antithrombotic agents 3
Apremilast Immunosuppressants 8
Argatroban Antithrombotic agents 1
Atorvastatin Lipid modifying agents 2
Atorvastatin calcium Lipid modifying agents 1
Atovaquone Antiprotozoals 1
Azacitidine Antineoplastic agents 5
Azelastine hydrochloride, fluticasone propionate Nasal preparations 1
Azithromycin Antibacterials for systemic use 1
Azithromycin dihydrate Antibacterials for systemic use 2
Bendamustine hydrochloride Antineoplastic agents 1
Betamethasone dipropionate, calcipotriol monohydrate Antipsoriatics 1
Bosentan Antihypertensives 1
Brimonidine tartrate Ophthalmologicals 1
Bromfenac sodium sesquihydrate Ophthalmologicals 1
Brupropion hydrochloride Psychoanaleptics 1
Buprenorphine hydrochloride, naloxone hydrochloride dihydrate Other nervous system drugs 1
Busulfan Antineoplastic agents 2
Caffeine Psychoanaleptics 2
Calcium polystyrene sulphonate All other therapeutic products 1
Canagliflozin Drugs used in diabetes 2
Carboprost tromethamine Other gynecologicals 1
Carvedilol Beta blocking agents 1
Caspofungin acetate Antimycotics for systemic use 1
Cephalexin monohydrate Antibacterials for systemic use 1
Clobetasol propionate Corticosteroids, dermatological preparations 1
Clonidine hydrochloride Antihypertensives 1
Colesevelam hydrochloride Lipid modifying agents 1
Cyclophosphamide Antineoplastic agents 1
Dantrolene sodium Muscle relaxants 1
Dapagliflozin Drugs used in diabetes 5
Dapagliflozin, metformin hydrochloride Drugs used in diabetes 1
Darunavir ethanolate Antivirals for systemic use 1
Dasatinib Antineoplastic agents 1
Deferasirox All other therapeutic products 5
Degarelix acetate Endocrine therapy 1
Desvenlafaxine succinate Psychoanaleptics 1
Diltiazem hydrochloride Calcium channel blockers 1
Dimethyl fumarate Immunosuppressants 8
Divalproex sodium Antiepileptics 1
Docetaxel Antineoplastic agents 2
Dolutegravir Antivirals for systemic use 1
Domperidone maleate Drugs for functional gastrointestinal disorders 1
Dorzolamide hydrochloride Ophthalmologicals 2
Dorzolamide hydrochloride, timolol maleate Ophthalmologicals 3
Doxepin hydrochloride Psychoanaleptics 2
Doxycycline Antibacterials for systemic use 1
Dutasteride Urologicals 1
Efinaconazole Antifungals for dermatological use 6
Eltrombopag olamine Antihemorrhagics 1
Emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Enzalutamide Endocrine therapy 2
Ethinyl estradiol, etonogestrel Other gynecologicals 2
Ethinyl estradiol, levonorgestrel Sex hormones and modulators of the genital system 1
Everolimus Antineoplastic agents 2
Felodipine Calcium channel blockers 1
Fesoterodine fumarate Urologicals 1
Fingolimod hydrochloride Immunosuppressants 1
Fludrocortisone 21-acetate Corticosteroids for systemic use 1
Fluoxetine hydrochloride Psychoanaleptics 2
Fondaparinux sodium Antithrombotic agents 1
Fulvestrant Endocrine therapy 3
Furosemide Diuretics 2
Fusidic acid Antibiotics and chemotherapy for dermatological use 1
Gefitinib Antineoplastic agents 1
Glatiramer acetate Immunostimulants 1
Glycopyrrolate Drugs for functional gastrointestinal disorders 1
Guanfacine hydrochloride Antihypertensives 2
Hydrochlorothiazide, olmesartan medoxomil Agents acting on the renin-angiotensin system 1
Hydromorphone hydrochloride Analgesics 1
Hydroxychloroquine sulfate Antiprotozoals 1
Ibrutinib Antineoplastic agents 3
Icatibant acetate Other hematological agents 4
Irinotecan hydrochloride trihydrate Antineoplastic agents 1
Ketamine hydrochloride Anesthetics 1
Ketorolac tromethamine Antiinflammatory and antirheumatic products 3
Labetalol hydrochloride Beta blocking agents 1
Lenalidomide Immunosuppressants 6
Lenalidomide hydrochloride Immunosuppressants 1
Letrozole Endocrine therapy 1
Lidocaine hydrochloride Cardiac therapy 1
Linagliptin Drugs used in diabetes 2
Linezolid Antibacterials for systemic use 1
Lisdexamfetamine dimestylate Psychoanaleptics 2
Lurasidone hydrochloride Psycholeptics 6
Macitentan Antihypertensives 3
Melphalan hydrochloride Antineoplastic agents 1
Metformin hydrochloride Drugs used in diabetes 2
Metformin hydrochloride, sitagliptin Drugs used in diabetes 2
Metformin hydrochloride, sitagliptin hydrochloride monohydrate Drugs used in diabetes 1
Metformin hydrochloride, sitagliptin malate Drugs used in diabetes 1
Metformin hydrochloride, sitagliptin phosphate Drugs used in diabetes 1
Metformin hydrochloride, sitagliptin phosphate monohydrate Drugs used in diabetes 3
Methadone hydrochloride Other nervous system drugs 1
Methotrexate Antineoplastic agents 1
Methylphenidate hydrochloride Psychoanaleptics 1
Micafungin sodium Antimycotics for systemic use 1
Milrinone Cardiac therapy 1
Mitomycin Antineoplastic agents 1
Mycophenolate mofetil Immunosuppressants 1
Naloxegol Drugs for constipation 1
Naloxone hydrochloride All other therapeutic products 1
Naltrexone hydrochloride Other nervous system drugs 1
Nebivolol hydrochloride Beta blocking agents 1
Ofloxacin Ophthalmologicals 1
Olmesartan medoxomil Agents acting on the renin-angiotensin system 1
Ondansetron hydrochloride dihydrate Antiemetics and antinauseants 1
Oseltamivir phosphate Antivirals for systemic use 2
Oxaliplatin Antineoplastic agents 1
Paliperidone Psycholeptics 1
Paliperidone palmitate Psycholeptics 3
Pemetrexed disodium Antineoplastic agents 1
Perampanel Antiepileptics 1
Perindopril erbumine Agents acting on the renin-angiotensin system 1
Plerixafor Immunostimulants 1
Pomalidomide Immunosuppressants 6
Posaconazole Antimycotics for systemic use 1
Pregabalin Antiepileptics 1
Propofol Anesthetics 1
Ranitidine Drugs for acid related disorders 1
Rasagiline mesylate Anti-Parkinson drugs 1
Riociguat Antihypertensives 1
Ritonavir Antivirals for systemic use 1
Rivaroxaban Antithrombotic agents 6
Rosuvastatin calcium Lipid modifying agents 1
Sapropterin dihydrochloride Other alimentary tract and metabolism products 1
Silodosin Urologicals 1
Sitagliptin Drugs used in diabetes 2
Sitagliptin malate Drugs used in diabetes 2
Sitagliptin phosphate Drugs used in diabetes 2
Sitagliptin phosphate monohydrate Drugs used in diabetes 1
Sulfamethoxazole, trimethoprim Antibacterials for systemic use 1
Sumatriptan succinate Analgesics 1
Sunitinib Antineoplastic agents 2
Sunitinib malate Antineoplastic agents 3
Tacrolimus Immunosuppressants 2
Tadalafil Urologicals 1
Tamsulosin hydrochloride Urologicals 1
Teriflunomide Immunosuppressants 10
Thiotepa Antineoplastic agents 1
Ticagrelor Antithrombotic agents 3
Timolol maleate Ophthalmologicals 1
Tofacitinib Immunosuppressants 1
Tofacitinib citrate Immunosuppressants 3
Tolvaptan Diuretics 1
Trabectedin Antineoplastic agents 1
Treprostinil Antithrombotic agents 2
Tretinoin Antineoplastic agents 1
Valproic acid Antineoplastic agents 1
Varenicline tartrate Other nervous system drugs 2
Venlafaxine hydrochloride Psychoanaleptics 1
Voriconazole Antimycotics for systemic use 1
Vortioxetine hydrobromide Psychoanaleptics 2
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