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.

On this page

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 2
Acetaminophen, tramadol hydrochloride Analgesics 1
Acyclovir Antivirals for systemic use 2
Acyclovir sodium Antivirals for systemic use 1
Afatinib Antineoplastic agents 1
Afatinib dimaleate Antineoplastic agents 3
Alectinib hydrochloride Antineoplastic agents 1
Alfacalcidol Vitamins 1
Almotriptan malate Analgesics 1
Ambrisentan Antihypertensives 1
Amlodipine besylate, perindopril arginine Agents acting on the renin-angiotensin system 1
Amlodipine besylate, telmisartan Agents acting on the renin-angiotensin system 1
Amphotericin B Antimycotics for systemic use 1
Anastrozole Endocrine therapy 1
Apixaban Antithrombotic agents 1
Apremilast Immunosuppressants 1
Aprepitant Antiemetics and antinauseants 1
Atorvastatin calcium Lipid modifying agents 1
Atovaquone Antiprotozoals 1
Azelastine hydrochloride, fluticasone propionate Nasal preparations 2
Azilsartan medoxomil Agents acting on the renin-angiotensin system 1
Baclofen Muscle relaxants 3
Bendamustine hydrochloride Antineoplastic agents 1
Bilastine Antihistamines for systemic use 4
Bimatoprost Ophthalmologicals 3
Bisoprolol fumarate Beta blocking agents 1
Bortezomib Antineoplastic agents 1
Bortezomib mannitol boronic ester Antineoplastic agents 1
Brexpiprazole Psycholeptics 6
Brimonidine tartrate Ophthalmologicals 2
Brimonidine tartrate, timolol maleate Ophthalmologicals 1
Brivaracetam Antiepileptics 2
Bromfenac sodium sesquihydrate Ophthalmologicals 1
Buffer solution, melphalan hydrochloride Antineoplastic agents 1
Buprenorphine Analgesics 1
Bupropion hydrochloride Psychoanaleptics 2
Cabazitaxel Antineoplastic agents 1
Calcitrol Vitamins 1
Calcium polystyrene sulphonate All other therapeutic products 1
Canagliflozin Drugs used in diabetes 3
Carbamazepine Antiepileptics 1
Carboprost tromethamine Other gynecologicals 1
Carfilzomib Antineoplastic agents 5
Cefadroxil monohydrate Antibacterials for systemic use 1
Cefuroxime axetil Antibacterials for systemic use 1
Celecoxib Antiinflammatory and antirheumatic products 1
Ciclopirox Antifungals for dermatological use 1
Citalopram hydrobromide Psychoanaleptics 1
Cladribine Immunosuppressants 1
Clopidogrel bisulfate Antithrombotic agents 1
Clozapine Psycholeptics 1
Colesevelam hydrochloride Lipid modifying agents 1
Cyclophosphamide Antineoplastic agents 1
Dapagliflozin Drugs used in diabetes 1
Dasatinib Antineoplastic agents 1
Deferasirox All other therapeutic products 2
Desmopressin acetate Pituitary and hypothalamic hormones and analogues 2
Dexlansoprazole Drugs for acid related disorders 1
Dexmedetomidine hydrochloride Psycholeptics 2
Dexrazoxane All other therapeutic products 1
Dienogest Sex hormones and modulators of the genital system 1
Divalproex sodium Antiepileptics 1
Dolutegravir Antivirals for systemic use 1
Domperidone maleate Drugs for functional gastrointestinal disorders 1
Donepezil hydrochloride monohydrate Psychoanaleptics 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
Doxycycline monohydrate Antibacterials for systemic use 1
Dutasteride Urologicals 1
Edoxaban tosylate Antithrombotic agents 1
Efinaconazole Antifungals for dermatological use 9
Empagliflozin Drugs used in diabetes 8
Empagliflozin, metformin hydrochloride Drugs used in diabetes 1
Emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide hemifumarate Antivirals for systemic use 1
Emtricitabine, tenofovir alafenamide Antivirals for systemic use 1
Emtricitabine, tenofovir alafenamide fumarate Antivirals for systemic use 1
Emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 2
Enzalutamide Endocrine therapy 3
Eplerenone Diuretics 2
Eribulin meslyate Antineoplastic agents 3
Ertapenem sodium Antibacterials for systemic use 1
Eslicarbazepine acetate Antiepileptics 2
Esomeprazole magnesium trihydrate Drugs for acid related disorders 1
Estradiol Sex hormones and modulators of the genital system 1
Eszopiclone Psycholeptics 1
Ethinyl estradiol, etonogestrel Other gynecologicals 1
Etoposide Antineoplastic agents 1
Febuxostat Antigout preparations 1
Fenofibrate Lipid modifying agents 1
Finasteride Other dermatological preparations 1
Fingolimod hydrochloride Immunosuppressants 1
Fluconazole Antimycotics for systemic use 1
Fludrocortisone 21-acetate Corticosteroids for systemic use 1
Fluoxetine hydrochloride Psychoanaleptics 1
Fluticasone propionate Drugs for obstructive airway diseases 1
Fosaprepitant dimeglumine Antiemetics and antinauseants 1
Fosfomycin Antibacterials for systemic use 1
Galantamine hydrobromide Psychoanaleptics 1
Gemcitabine hydrochloride Antineoplastic agents 2
Glatiramer acetate Immunostimulants 2
Granisetron hydrochloride Antiemetics and antinauseants 1
Haloperidol decanoate Psycholeptics 1
Hydrochlorothiazide, quinapril hydrochloride Agents acting on the renin-angiotensin system 1
Hydromorphone hydrochloride Analgesics 1
Hydroxychloroquine sulfate Antiprotozoals 1
Hydroxyurea Antineoplastic agents 1
Hyoscine butylbromide Drugs for functional gastrointestinal disorders 2
Ibrutinib Antineoplastic agents 4
Icatibant acetate Other hematological agents 1
Indapamide Diuretics 1
Indapamide, perindopril erbumine Agents acting on the renin-angiotensin system 1
Ipratropium bromide Drugs for obstructive airway diseases 1
Irbesartan Agents acting on the renin-angiotensin system 1
Ketamine hydrochloride Anesthetics 1
Ketoconazole Antimycotics for systemic use 1
Ketotifen hydrogen fumarate Ophthalmologicals 1
Labetalol hydrochloride Beta blocking agents 1
Lacosamide Antiepileptics 2
Lamotrigine Antiepileptics 1
Lanreotide acetate Pituitary and hypothalamic hormones and analogues 1
Latanoprost, timolol maleate Ophthalmologicals 1
Leflunomide Immunosuppressants 1
Lenalidomide Immunosuppressants 1
Letrozole Endocrine therapy 1
Leucovorin calcium All other therapeutic products 2
Levetiracetam Antiepileptics 5
Levothyroxine sodium Thyroid therapy 1
Lidocaine, prilocaine Antipruritics, including antihistamines, anesthetics, etc. 1
Linagliptin Drugs used in diabetes 8
Linagliptin, metformin hydrochloride Drugs used in diabetes 1
Liothyronine sodium Thyroid therapy 2
Liraglutide Drugs used in diabetes 1
Lisdexamfetamine dimesylate Psychoanaleptics 6
Lorazepam Psycholeptics 1
Lurasidone hydrochloride Psycholeptics 1
Macitentan Antihypertensives 7
Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 1
Metformin hydrochloride, sitagliptin Drugs used in diabetes 2
Metformin hydrochloride, sitagliptin phosphate monohydrate Drugs used in diabetes 1
Methadone hydrochloride Other nervous system drugs 1
Methotrexate Antineoplastic agents 3
Methotrexate disodium Antineoplastic agents 1
Methylphenidate hydrochloride Psychoanaleptics 1
Metoclopramide hydrochloride Drugs for functional gastrointestinal disorders 1
Micafungin sodium Antimycotics for systemic use 3
Mirabegron Urologicals 2
Mirtazapine Psychoanaleptics 1
Misoprostol Drugs for acid related disorders 1
Moxifloxacin hydrochloride Ophthalmologicals 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 2
Naloxone hydrochloride dihydrate All other therapeutic products 1
Naratriptan hydrochloride Analgesics 1
Nebivolol hydrochloride Beta blocking agents 2
Nelarabine Antineoplastic agents 2
Nifedipine Calcium channel blockers 2
Nilotinib hydrochloride monohydrate Antineoplastic agents 2
Nintedanib Antineoplastic agents 1
Nintedanib esylate Antineoplastic agents 2
Nitrofurantoin Antibacterials for systemic use 1
Nortriptyline hydrochloride Psychoanaleptics 2
Ofloxacin Ophthalmologicals 1
Olopatadine hydrochloride Ophthalmologicals 5
Ondansetron Antiemetics and antinauseants 1
Ondansetron hydrochloride dihydrate Antiemetics and antinauseants 1
Oxybutynin chloride Urologicals 1
Palbociclib Antineoplastic agents 3
Paliperidone Psycholeptics 1
Paliperidone palmitate Psycholeptics 3
Paroxetine hydrochloride Psychoanaleptics 1
Pazopanib hydrochloride Antineoplastic agents 1
Pentoxifylline Peripheral vasodilators 1
Perampanel Antiepileptics 1
Piperacillin sodium, tazobactam sodium Antibacterials for systemic use 1
Pirfenidone Immunosuppressants 1
Plerixafor Immunostimulants 1
Pomalidomide Immunosuppressants 1
Posaconazole Antimycotics for systemic use 4
Pravastatin sodium Lipid modifying agents 1
Propranolol hydrochloride Beta blocking agents 2
Prucalopride succinate Drugs for constipation 1
Quinapril Agents acting on the renin-angiotensin system 1
Raloxifene hydrochloride Sex hormones and modulators of the genital system 1
Regorafenib Antineoplastic agents 1
Riociguat Antihypertensives 1
Risperidone Psycholeptics 1
Rivaroxaban Antithrombotic agents 12
Rivastigmine Psychoanaleptics 1
Rivastigmine hydrogen tartrate Psychoanaleptics 1
Rufinamide Antiepileptics 1
Rupatadine fumarate Antihistamines for systemic use 1
Ruxolitinib phosphate Antineoplastic agents 1
Sacubitril, valsartan Agents acting on the renin-angiotensin system 2
Sapropterin dihydrochloride Other alimentary tract and metabolism products 3
Selexipag Antithrombotic agents 1
Sevelamer carbonate All other therapeutic products 1
Sevelamer hydrochloride All other therapeutic products 1
Sevoflurane Anesthetics 1
Sildenafil citrate Antihypertensives 1
Sitagliptin Drugs used in diabetes 1
Sitagliptin phosphate Drugs used in diabetes 2
Sitagliptin phosphate monohydrate Drugs used in diabetes 2
Sodium nitroprusside Antihypertensives 1
Sodium valproate Antiepileptics 1
Sugammadex sodium All other therapeutic products 10
Sulfamethoxazole, trimethoprim Antibacterials for systemic use 1
Sulfasalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 1
Sumatriptan succinate Analgesics 2
Sunitinib malate Antineoplastic agents 1
Tacrolimus Immunosuppressants 2
Tamsulosin hydrochloride Urologicals 1
Tenofovir alafenamide fumarate Antivirals for systemic use 3
Terbinafine hydrochloride Antifungals for dermatological use 2
Testosterone enanthate Sex hormones and modulators of the genital system 1
Timolol maleate Ophthalmologicals 1
Timolol maleate, travoprost Ophthalmologicals 1
Tiotropium bromide monohydrate Drugs for obstructive airway diseases 1
Tobramycin Antibacterials for systemic use 1
Tofacitinib citrate Immunosuppressants 1
Trabectedin Antineoplastic agents 1
Tranexamic acid Antihemorrhagics 1
Tranylcypromine sulfate Psychoanaleptics 1
Travoprost Ophthalmologicals 2
Treosulfan Antineoplastic agents 1
Vancomycin hydrochloride Antibacterials for systemic use 1
Varenicline tartrate Other nervous system drugs 1
Vilazodone hydrochloride Psychoanaleptics 1
Voriconazole Antimycotics for systemic use 1
Vortioxetine hydrobromide Psychoanaleptics 3
Zopiclone Psycholeptics 1

Page details

Date modified: