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 3
Acetaminophen Analgesics 1
Acetylcysteine Cough and cold preparations 1
Acyclovir Antivirals for systemic use 1
Afatinib Antineoplastic agents 1
Afatinib dimaleate Antineoplastic agents 3
Alendronic acid, vitamin D3 Drugs for treatment of bone diseases 1
Allopurinol Antigout preparations 1
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
Apixaban Antithrombotic agents 3
Apremilast Immunosuppressants 8
Argatroban Antithrombotic agents 1
Atorvastatin Lipid modifying agents 1
Atorvastatin calcium Lipid modifying agents 1
Atovaquone Antiprotozoals 1
Azacitidine Antineoplastic agents 4
Bendamustine hydrochloride Antineoplastic agents 2
Betahistine hydrochloride Other nervous system drugs 1
Betamethasone dipropionate, calcipotriol monohydrate Antipsoriatics 1
Bisoprolol fumarate Beta blocking agents 1
Bivalirudin Antithrombotic agents 1
Bosentan Antihypertensives 1
Brimonidine tartrate Ophthalmologicals 1
Buprenorphine hydrochloride, naloxone hydrochloride dihydrate Other nervous system drugs 1
Buspirone hydrochloride Psycholeptics 1
Busulfan Antineoplastic agents 2
Calcium polystyrene sulphonate All other therapeutic products 1
Canagliflozin Drugs used in diabetes 2
Carbidopa, entacapone, levodopa Anti-parkinson drugs 1
Carboprost tromethamine Other gynecologicals 1
Caspofungin acetate Antimycotics for systemic use 1
Cephalexin monohydrate Antibacterials for systemic use 1
Cetirizine hydrochloride Antihistamines for systemic use 1
Clobetasol propionate Corticosteroids, dermatological preparations 1
Clonidine hydrochloride Antihypertensives 2
Cyclosporine Ophthalmologicals 1
Dantrolene sodium Muscle relaxants 1
Dapagliflozin Drugs used in diabetes 4
Daptomycin Antibacterials for systemic use 1
Darifenacin hydrobromide Urologicals 1
Darunavir ethanolate Antivirals for systemic use 1
Dasatinib Antineoplastic agents 1
Deferasirox All other therapeutic products 4
Degarelix acetate Endocrine therapy 1
Desvenlafaxine succinate Psychoanaleptics 1
Dimethyl fumarate Immunosuppressants 9
Dipyridamole Antithrombotic agents 1
Divalproex sodium Antiepileptics 1
Docetaxel Antineoplastic agents 2
Dolutegravir Antivirals for systemic use 1
Domperidone Drugs for functional gastrointestinal disorders 1
Domperidone maleate Drugs for functional gastrointestinal disorders 1
Dorzolamide hydrochloride, timolol maleate Ophthalmologicals 1
Doxepin hydrochloride Psychoanaleptics 2
Doxycycline Antibacterials for systemic use 1
Efavrienz, emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Efinaconazole Antifungals for dermatological use 7
Eltrombopag olamine Antihemorrhagics 1
Emtricitabine, tenofovir disoproxil fumarate Antivirals for systemic use 1
Enzalutamide Endocrine therapy 2
Ethinyl estradiol, etonogestrel Other gynecologicals 1
Ethinyl estradiol, levonorgestrel Sex hormones and modulators of the genital system 1
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
Fulvestrant Endocrine therapy 2
Furosemide Diuretics 3
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 1
Hydralazine hydrochloride Antihypertensives 1
Hydrochlorothiazide, olmesartan medoxomil Agents acting on the renin-angiotensin system 1
Hydromorphone hydrochloride Analgesics 1
Hydroxychloroquine sulfate Antiprotozoals 1
Ibrutinib Antineoplastic agents 1
Icatibant acetate Other hematological agents 3
Irinotecan hydrochloride trihydrate Antineoplastic agents 1
Ketorolac tromethamine Antiinflammatory and antirheumatic products 3
Labetalol hydrochloride Beta blocking agents 1
Lenalidomide Immunosuppressants 6
Lenalidomide hydrochloride Immunosuppressants 1
Lidocaine hydrochloride Cardiac therapy 1
Linagliptin Drugs used in diabetes 2
Linezolid Antibacterials for systemic use 1
Lurasidone hydrochloride Psycholeptics 6
Macitentan Antihypertensives 3
Medroxyprogesterone acetate Sex hormones and modulators of the genital system 1
Melphalan hydrochloride Antineoplastic agents 1
Metformin hydrochloride Drugs used in diabetes 1
Metformin hydrochloride, sitagliptin 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
Methotrexate sodium Antineoplastic agents 1
Methylprednisolone acetate Corticosteroids for systemic use 1
Metoclopramide hydrochloride Drugs for functional gastrointestinal disorders 1
Micafungin sodium Antimycotics for systemic use 2
Midodrine hydrochloride Cardiac therapy 1
Milrinone Cardiac therapy 1
Mitomycin Antineoplastic agents 1
Naloxone hydrochloride All other therapeutic products 2
Naltrexone hydrochloride Other nervous system drugs 1
Nebivolol hydrochloride Beta blocking agents 1
Olmesartan medoxomil Agents acting on the renin-angiotensin system 1
Ondansetron hydrochloride dihydrate Antiemetics and antinauseants 1
Oseltamivir phosphate Antivirals for systemic use 1
Paliperidone Psycholeptics 1
Paliperidone palmitate Psycholeptics 2
Pantoprazole sodium sesquihydrate Drugs for acid related disorders 1
Pemetrexed disodium hemipentahydrate Antineoplastic agents 1
Pentamidine isetionate Antiprotozoals 1
Perampanel Antiepileptics 1
Perindopril erbumine Agents acting on the renin-angiotensin system 1
Pirfenidone Immunosuppressants 5
Plerixafor Immunostimulants 1
Pomalidomide Immunosuppressants 6
Quinapril hydrochloride Agents acting on the renin-angiotensin system 1
Ritonavir Antivirals for systemic use 1
Rivaroxaban Antithrombotic agents 7
Rocuronium bromide Muscle relaxants 1
Rosuvastatin calcium Lipid modifying agents 1
Sapropterin dihydrochloride Other alimentary tract and metabolism products 1
Silodosin Urologicals 1
Sitagliptin Drugs used in diabetes 1
Sitagliptin hydrochloride monohydrate Drugs used in diabetes 1
Sitagliptin malate Drugs used in diabetes 2
Sitagliptin phosphate Drugs used in diabetes 2
Sitagliptin phosphate monohydrate Drugs used in diabetes 1
Spironolactone Diuretics 1
Sulfamethoxazole, trimethoprim Antibacterials for systemic use 1
Sumatriptan succinate Analgesics 3
Sunitinib Antineoplastic agents 2
Sunitinib malate Antineoplastic agents 2
Tacrolimus Immunosuppressants 2
Tadalafil Urologicals 2
Tamsulosin hydrochloride Urologicals 1
Temozolomide Antineoplastic agents 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
Tramadol hydrochloride Analgesics 1
Treprostinil Antithrombotic agents 2
Tretinoin Antineoplastic agents 1
Valproic acid Antineoplastic agents 1
Vancomycin hydrochloride Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 1
Varenicline tartrate Other nervous system drugs 2

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