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
- Finding information on the list
- Decisions
- Other lists of submissions under review
- View the list
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:
- medicinal ingredient(s)
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
- number of ANDSs under review with Health Canada that month
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.
| 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: