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.

Antibacterials for systemic use Fluticasone propionate Drugs for obstructive airway diseases Gatifloxacin Ophthalmologicals Nelarabine Antineoplastic agents Timolol maleate Ophthalmologicals 1
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 1
Acyclovir Antivirals for systemic use 1
Acyclovir sodium Antivirals for systemic use 1
Afatinib Antineoplastic agents 1
Afatinib dimaleate Antineoplastic agents 3
Allopurinol Antigout preparations 1
Almotriptan malate Analgesics 1
Amantadine hydrochloride Anti-Parkinson drugs 1
Ambrisentan Antihypertensives 1
Amiodarone hydrochloride Cardiac therapy 1
Amoxicillin Antibacterials for systemic use 1
Amoxicillin, clavulanate potassium Antibacterials for systemic use 1
Amoxicillin trihydrate Antibacterials for systemic use 2
Amoxicillin trihydrate, clavulanic acid Antibacterials for systemic use 1
Amphotericin B Antimycotics for systemic use 1
Anastrozole Endocrine therapy 1
Apixaban Antithrombotic agents 4
Apremilast Immunosuppressants 10
Argatroban Antithrombotic agents 1
Atorvastatin Lipid modifying agents 1
Azacitidine Antineoplastic agents 4
Azelastine hydrochloride, fluticasone propionate Nasal preparations 2
Azilsartan medoxomil Agents acting on the renin-angiotensin system 1
Betahistine hydrochloride Other nervous system drugs 1
Bilastine Antihistamines for systemic use 4
Bimatoprost Ophthalmologicals 1
Bisoprolol fumarate Beta blocking agents 1
Bortezomib mannitol boronic ester Ophthalmologicals 1
Brimonidine tartrate, timolol maleate Ophthalmologicals 1
Brivaracetam Antiepileptics 2
Bromfenac sodium sesquihydrate Ophthalmologicals 3
Bupropion hydrochloride Psychoanaleptics 1
Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 1
Buffer solution, melphalan hydrochloride Antineoplastic agents 1
Buprenorphine Analgesics 1
Cabazitaxel Antineoplastic agents 2
Calcium polystyrene sulphonate All other therapeutic products 1
Canagliflozin Drugs used in diabetes 2
Carbamazepine Antiepileptics 1
Carboprost tromethamine Other gynecologicals 1
Carfilzomib Antineoplastic agents 3
Carmustine Antineoplastic agents 1
Celecoxib Antiinflammatory and antirheumatic products 1
Cisplatin Antineoplastic agents 1
Citalopram hydrobromide Psychoanaleptics 2
Clobetasol propionate Corticosteroids, dermatological preparations 1
Clozapine Psycholeptics 1
Colesevelam hydrochloride Lipid modifying agents 1
Cyclophosphamide Antineoplastic agents 1
Dapagliflozin Drugs used in diabetes 11
Dapagliflozin, metformin hydrochloride Drugs used in diabetes 1
Daptomycin Antibacterials for systemic use 1
Dasatinib Antineoplastic agents 2
Daunorubicin hydrochloride Antineoplastic agents 1
Deferasirox All other therapeutic products 3
Degarelix acetate Endocrine therapy 1
Desmopressin acetate Pituitary and hypothalamic hormones and analogues 1
Desvenlafaxine Psychoanaleptics 1
Dexlansoprazole Drugs for acid related disorders 1
Dexmedetomidine hydrochloride Psycholeptics 1
Diclofenac sodium Ophthalmologicals 1
Diltiazem hydrochloride Calcium channel blockers 1
Divalproex sodium Antiepileptics 1
Docetaxel Antineoplastic agents 1
Dolutegravir Antivirals for systemic use 1
Domperidone maleate Drugs for functional gastrointestinal disorders 1
Dorzolamide hydrochloride Ophthalmologicals 1
Dorzolamide hydrochloride, timolol maleate Ophthalmologicals 1
Doxepin hydrochloride Psychoanaleptics 2
Doxorubicin hydrochloride Antineoplastic agents 1
Doxycycline Antibacterials for systemic use 1
Doxycycline hyclate Antibacterials for systemic use 1
Dutasteride Urologicals 1
Efinaconazole Antifungals for dermatological use 9
Eltrombopag olamine Antihemorrhagics 1
Empagliflozin Drugs used in diabetes 4
Empagliflozin, metformin hydrochloride Drugs used in diabetes 1
Emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide hemifumarate Antivirals for systemic use 1
Emtricitabine, tenofovir alafenamide fumarate Antivirals for systemic use 2
Emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 2
Entacapone Anti-parkinson drugs 1
Enzalutamide Endocrine therapy 3
Ertapenem sodium Antibacterials for systemic use 1
Eslicarbazepine acetateAntiepileptics 1
Ethinyl estradiol, etonogestrel Other gynecologicals 1
Ethinyl estradiol, levonorgestrel Sex hormones and modulators of the genital system 1
Everolimus Antineoplastic agents 2
Febuxostat Antigout preparations 2
Fenofibrate Lipid modifying agents 1
Fesoterodine fumarate Urologicals 1
Fingolimod hydrochloride Immunosuppressants 1
Fluoxetine hydrochloride Psychoanaleptics 1
Fluticasone propionate Drugs for obstructive airway diseases 1
Fondaparinux sodium Antithrombotic agents 1
FulvestrantEndocrine therapy 3
Gabapentin Antiepileptics 2
Gatifloxacin Ophthalmologicals 1
Gefitinib Antineoplastic agents 1
Gemcitabine hydrochloride Antineoplastic agents 1
Glatiramer acetateImmunostimulants 1
Glycopyrrolate Drugs for functional gastrointestinal disorders 2
Hydrochlorothiazide, quinapril hydrochloride Agents acting on the renin-angiotensin system 1
Hydroxyurea Antineoplastic agents 1
Ibrutinib Antineoplastic agents 3
Icatibant acetate Other hematological agents 4
Indapamide, perindopril erbumine Agents acting on the renin-angiotensin system 1
Ipratropium bromide Drugs for obstructive airway diseases 1
Ketamine hydrochloride Anesthetics 1
Ketorolac tromethamine Antiinflammatory and antirheumatic products 2
Ketotifen hydrogen fumarate Ophthalmologicals 1
Labetalol hydrochloride Beta blocking agents 2
Lacosamide Antiepileptics 1
Lamotrigine Antiepileptics 1
Latanoprost, timolol maleate Ophthalmologicals 1
Lenalidomide hydrochloride Immunosuppressants 1
Leucovorin calcium All other therapeutic products 1
Levetiracetam Antiepileptics 2
Levothyroxine sodium Thyroid therapy 1
Lidocaine, prilocaine Antipruritics, including antihistamines, anesthetics, etc. 1
Linagliptin Drugs used in diabetes 5
Linagliptin, metformin hydrochloride Drugs used in diabetes 1
Liraglutide Drugs used in diabetes 2
Lisdexamfetamine dimesylate Psychoanaleptics 5
Lurasidone hydrochloride Psycholeptics 2
Macitentan Antihypertensives 6
Memantine hydrochloride Psychoanaleptics 1
Meropenem trihydrate Antibacterials for systemic use 1
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 1
Metformin hydrochloride Drugs used in diabetes 5
Metformin hydrochloride, sitagliptin Drugs used in diabetes 3
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
Metformin hydrochloride, sitagliptin tartrate Drugs used in diabetes 1
Methadone hydrochloride Other nervous system drugs 2
Methylphenidate hydrochloride Psychoanaleptics 3
Metoclopramide hydrochloride Drugs for functional gastrointestinal disorders 1
Micafungin sodium Antimycotics for systemic use 2
Milrinone Cardiac therapy 1
Mirtazapine Psychoanaleptics 1
Mitomycin Antineoplastic agents 1
Mycophenolate mofetil Immunosuppressants 1
Mycophenolate sodium Immunosuppressants 1
Nadolol Beta blocking agents 1
Naloxegol Drugs for constipation 1
Naloxone hydrochloride All other therapeutic products 1
Nebivolol hydrochloride Beta blocking agents 2
Nelarabine Antineoplastic agents 2
Nifedipine Calcium channel blockers 1
Nintedanib Antineoplastic agents 1
Nintedanib esylate Antineoplastic agents 2
Nortriptyline hydrochloridePsychoanaleptics 2
Ofloxacin Ophthalmologicals 1
Olopatadine hydrochloride Ophthalmologicals 1
Ondansetron Antiemetics and antinauseants 1
Ondansetron hydrochloride dihydrate Antiemetics and antinauseants 2
Oseltamivir phosphate Antivirals for systemic use 1
Oxaliplatin Antineoplastic agents 1
Palbociclib Antineoplastic agents 1
Paliperidone Psycholeptics 1
Paliperidone palmitate Psycholeptics 3
Pantoprazole sodium sesquihydrate Drugs from acid related disorders 1
Pemetrexed disodium Antineoplastic agents 1
Perampanel Antiepileptics 1
Piperacillin sodium, tazobactam sodium Antibacterials for systemic use 2
Pirfenidone Immunosuppressants 1
Plerixafor Immunostimulants 1
Pomalidomide Immunosuppressants 7
Posaconazole Antimycotics for systemic use 4
Prucalopride succinate Drugs for constipation 1
Quinapril Agents acting on the renin-angiotensin system 1
Rasagiline mesylate Anti-Parkinson drugs 1
Regorafenib Antineoplastic agents 1
Riociguat Antihypertensives 1
Risperidone Psycholeptics 1
Rivaroxaban Antithrombotic agents 7
Rivastigmine hydrogen tartrate Psychoanaleptics 1
Sacubitril, valsartan Agents acting on the renin-angiotensin system 1
Sapropterin dihydrochloride Other alimentary tract and metabolism products 2
Selexipag Antithrombotic agents 1
Sevelamer carbonate All other therapeutic products 1
Sevoflurane Anesthetics 1
Silodosin Urologicals 1
Sitagliptin Drugs used in diabetes 3
Sitagliptin fumarate Drugs used in diabetes 1
Sitagliptin hydrochloride 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 2
Sodium valproate Antiepileptics 1
Sugammadex sodium All other therapeutic products 6
Sumatriptan succinate Analgesics 3
Sunitinib Antineoplastic agents 1
Sunitinib malate Antineoplastic agents 3
Tacrolimus Immunosuppressants 1
Tenofovir alafenamide fumarate Antivirals for systemic use 3
Terbinafine hydrochloride Antifungals for dermatological use 2
Thiotepa Antineoplastic agents 1
Ticagrelor Antithrombotic agents 1
Timolol maleate Ophthalmologicals 1
Tiotropium bromide monohydrate Drugs for obstructive airway diseases 1
Tizanidine hydrochloride Muscle relaxants 1
Tobramycin sulfate Antibacterials for systemic use 1
Tofacitinib Immunosuppressants 1
Tofacitinib citrateImmunosuppressants5
Tolvaptan Diuretics 1
Trabectedin Antineoplastic agents 1
Travoprost Ophthalmologicals 1
Trimebutine maleate Drugs for functional gastrointestinal disorders 1
Valganciclovir hydrochloride Antivirals for systemic use 1
Valproic acid Antineoplastic agents 1
Vancomycin hydrochloride Antibacterials for systemic use 2
Varenicline tartrate Other nervous system drugs 1
Vortioxetine hydrobromide Psychoanaleptics 3
Zinc sulfate heptahydrate Mineral supplements 1
Zolpidem tartrate Psycholeptics 1
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