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Drugs and Health Products
Listing of Drugs Currently Regulated as New Drugs
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This list represents substances and formulations which have been assessed by the Therapeutic Products Directorate on the basis of an application to market or further to promotion of products for medicinal purposes where safety and efficacy for such purposes have not been established.
This listing is not all-encompassing due in part to the complexity of Division 8 of the Food and Drug Regulations. It should be used as a guide only in determining the status of subsequent market entry drug products. This listing will be updated periodically.
"drug" includes any substance or mixture of substances manufactured, sold or represented for use in
- the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals,
- restoring, correcting or modifying organic functions in human beings or animals, or
- disinfection in premises in which food is manufactured, prepared or kept;
(Section 2 of the Food and Drugs Act)
"new drug" means
- a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;
- a drug that is a combination or two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or
- a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.
(Division 8 of the Food and Drugs Regulations)
Please note: Unless otherwise indicated, all dosage forms and routes are included.
Revised
| Drug | Form/Route |
|---|---|
| * Bold indicates new additions to the list | |
| Acarbose | |
| Acebutolol and its salts | |
| Acetaminophen | rectal suppository |
| Acetaminophen / Belladonna | |
| Acetaminophen / Butalbital | |
| Acetaminophen / Butalbital / Caffeine | |
| Acetaminophen / Butalbital / Caffeine / Codeine | |
| Acetaminophen / Butalbital / Codeine | |
| Acetaminophen/Diphenhydramine (as a sleep aid) | |
| Acetaminophen/Pseudoephedrine (for the treatment of earache) | |
| Acetylcysteine (mucolytic, antidote for acetaminophen poisoning) | |
| Acetylene/Carbon Monoxide/Methane/ Nitrogen/Oxygen | |
| Acetylsalicylic Acid (Anti-platelet) | |
| Acetylsalicylic Acid/ Diphenhydramine (as a sleep aid) | |
| Acitretin | |
| Acyclovir and its salts | |
| Adenosine and its salts1 | |
| Adapalene | |
| Alatrofloxacin and its salts | |
| Alclometasone and its salts | |
| Alfentanil and its salts | |
| Alkyl Salicylates | Spray or Aerosol - as per I.L. 659 |
| Allopurinol | |
| Alprazolam | |
| Alteplase | |
| Altretamine | |
| Amantadine and its salts | |
| Amcinonide | |
| Amikacin and its salts | |
| Amiloride and its salts | |
| Amino Acids [Tryptophan, Arginine, Ornithine, Phenylalanine, Tyrosine, Lysine, Carnitine, Methionine (other than Lipotropic Factor)] 2 | |
| Amino Acids (Total Parenteral Nutrition Products) | injection |
| Aminocaproic Acid | |
| Aminoglutethemide | |
| Aminophylline | suppository, oral modified release preparation |
| Aminosalicylic Acid (5-) | |
| Amiodarone and its salts | |
| Amitriptyline / Perphenzine | |
| Amlodipine and its salts and esters | |
| Ammonium Chloride (single active ingredient, except in homeopathic preparations) | |
| Ammonium Molybdate | |
| Amodiaquine | |
| Amoxicillin and its salts | |
| Amphotericin B | |
| Amrinone and its salts | |
| Anagrelide and its salts | |
| Anastrozole | |
| Apomorphine and its salts | |
| Apraclonidine and its salts | |
| Aprotonin | |
| Articaine and its salts | |
| Articaine HCl/Epinephrine | |
| Asparaginase | |
| Aspartates | |
| Astemizole | |
| Atenolol and its salts | |
| Atorvastatin and its salts | |
| Atovaquone | |
| Atracurium and its salts and esters | |
| Atropine and its salts | oral tablet |
| Auranofin | |
| Azathioprine and its salts | |
| Azelaic Acid | |
| Azithromycin and its salts | |
| Aztreonam and its salts | |
| Baclofen and its salts | |
| Bambuterol and its salts | |
| Beclomethasone and its salts | |
| Benazepril and its salts | |
| Benzalkonium Chloride/Boric Acid | |
| Benzoyl Peroxide/Erythromycin | |
| Benzoyl Peroxide/Titanium Dioxide | |
| Betahistine and its salts | |
| Betaine Anhydrous (for the treatment of homocystinuria) | |
| Betamethasone and its salts | rectal enema, injection |
| Betamethasone Dipropionate/Clotrimazole | |
| Betamethasone/Gentamicin | ophthalmic/otic |
| Betaxolol and its salts | |
| Bezafibrate | |
| Bicalutamide | |
| Biperiden and its salts | |
| Bismuth subcitrate(when used in combination to eradicate H. Pylori) | |
| Bisoprolol and its salts | |
| Bleomycin and its salts | |
| Boron | oral |
| Bretylium Tosylate | |
| Brimonidine and its salts | |
| Brinzolamide | |
| Bromazepam and its salts | |
| Bromocriptine and its salts | |
| Budesonide | |
| Bumetanide and its salts | |
| Bupivacaine and its salts | |
| Buprenorphine and its salts | |
| Bupropion and its salts | |
| Buserelin and its salts | |
| Buspirone and its salts | |
| Butenafine and its salts | |
| Butorphanol and its salts | |
| Caffeine/Ephedrine | |
| Calcipotriol | |
| Calcitonin Salmon Synthetic | |
| Calcitriol | |
| Calcium Acetate (for the control of hyperphosphatemia) | |
| Calcium Carbaspirin | |
| Calcium Glycerophosphate | injection |
| Calcium Polystyrene Sulphonate | |
| Candesartan Cilexetil | |
| Capecitabine | |
| Caprylic Acid3 | |
| Captopril and its salts | |
| Carbamazapine | |
| Carbetocin | |
| Carbidopa and its salts | |
| Carbocysteine | |
| Carbon Monoxide/ Methane/ Nitrogen/ Oxygen | |
| Carboplatin | |
| Carboprost and its salts | |
| Carvedilol | |
| Cefaclor | |
| Cefadroxil | |
| Cefazolin and its salts | |
| Cefdinir | |
| Cefixime and its salts | |
| Cefonicid and its salts | |
| Cefotaxime and its salts | |
| Cefotetan and its salts | |
| Cefoxitin and its salts | |
| Cefpodoxime and its salts | |
| Cefprozil | |
| Ceftazidime | |
| Ceftibuten Dihydrate | |
| Ceftizoxime and its salts | |
| Cefuroxime | |
| Centella4 | |
| Cephalexin (Monohydrate) | |
| Cephalothin and its salts | |
| Cerivastatin | |
| Cetirizine and its salts | |
| Chitosan | |
| Chloramphenicol | tablet |
| Chloramphenicol / Hydrocortisone / Butoxyethylnicotinate | topical |
| Chlordiazepoxide / Clidinium and its salts | |
| Chlorhexidine and its salts | oral rinse and dental solution |
| Chlormezanone | |
| Cholestyramine Resin | |
| Choline Theophyllinate | |
| Chondroitin and its salts3 | |
| Chromic Chloride | injection |
| Chromium Chloride Hexahydrate | injection |
| Chymopapain | |
| Ciclopirox and its salts | |
| Cilazapril and its salts | |
| Cimetidine and its salts | |
| Ciprofloxacin and its salts | |
| Cisapride | |
| Cisatracurium and its salts | |
| Cisplatin | |
| Citalopram and its salts | |
| Cladribine | |
| Clarithromycin | |
| Clindamycin and its salts | |
| Clobazam and its salts | |
| Clobetasol and its salts | |
| Clodronic Acid and its salts | |
| Clofibrate | |
| Clomiphene and its salts | |
| Clomipramine and its salts | |
| Clonazepam and its salts | |
| Clonidine and its salts | |
| Clopidogrel and its salts | |
| Clorazepic Acid and its salts | |
| Clotrimazole | |
| Clozapine and its salts | |
| Co-enzyme Q-10 (other than as source of Co-enzyme Q-10 or Ubiquinone) | |
| Co-Trimoxazole | |
| Codeine Polistirex/Chlorpheniramine Polistirex | |
| Codeine Sulphate | oral modified release |
| Colestipol and its salts | |
| Colfosceril Palmitate | |
| Coryceptin (Jing Ahi Dongchongxiacao) | |
| Cromolyn and its salts | |
| Cupric Sulfate | injection |
| Cyclobenzaprine and its salts | |
| Cyclosporine | |
| Cyproterone and its salts | |
| Cytarabine and its salts | |
| Dacarbazine | |
| Dalteparin and its salts | |
| Danaparoid and its salts | |
| Danazol and its salts | |
| Dantrolene and its salts | |
| Dapiprazole and its salts | |
| Daunorubicin and its salts | |
| Deferoxamine and its salts | |
| Delavirdine and its salts | |
| Deprenyl and its salts | |
| Desflurane | |
| Desipramine and its salts | |
| Desmopressin and its salts | |
| Desonide and its salts | |
| Desoximetasone | |
| Devil's Claw ( as antiinflammatory/ analgesic or except as per THM Policy) | |
| Dexamethasone (in combination) | ophthalmic / otic preparation |
| Dexfenfluramine and its salts | |
| Dexrazoxane | |
| Dextran | liquid IV |
| Dextrothyroxine and its salts | |
| Diatrizoic Acid and its salts | |
| Diazepam | |
| Dibencozide (other than source of Vitamin B12) | |
| Diclofenac and its salts | |
| Didanosine and its salts and derivatives | |
| Diethylpropion and its salts | |
| Diflucortolone and its salts | |
| Diflunisal and its salts | |
| Dihydroepiandrosterone (DHEA) (Prasterone)5 | |
| Dihydroergotamine and its salts | nasal |
| Diltiazem and its salts | |
| Dimenhydrinate | chewing gum |
| Dimethylglycine (DMG) | |
| Dimethyl Sulfoxide | |
| Dinoprostone | |
| Diphenidol and its salts | |
| Diphenoxylate and its salts | |
| Dipivefrin and its salts | |
| Dipyridamole | |
| Dirithromycin | |
| Disopyramide and its salts | |
| Divalproex and its salts | |
| Dobutamine and its salts | |
| Docetaxel | |
| Docosahexanoic Acid (DHA)6 | |
| Dolasetron and its salts | |
| Domperidone and its salts | |
| Dong Quai (except as per the THM Policy)7 | |
| Dopamine and its salts | |
| Doxacurium and its salts | |
| Doxapram and its salts | |
| Doxazosin and its salts | |
| Doxepin and its salts | |
| Doxorubicin and its salts | |
| Doxycycline and its salts | |
| Doxylamine Succinate (night time sleep aid) | |
| Droperidol and its salts | |
| Echothiophate Iodide | |
| Econazole and its salts | |
| Edetic Acid and its salts | injection |
| Edoxudine | |
| Edrophonium and its salts | |
| Eicosapentaenoic Acid (EPA)6 | |
| Electrolytes (Total Parenteral Nutrition Products) | |
| Emedastine and its salts | |
| Enalapril and its salts | |
| Enalaprilat and its salts | |
| Enflurane | |
| Enoxacin and its salts | |
| Enoxaparin and its salts | |
| Epirubicin and its salts | |
| Epoprostenol and its salts | |
| Erythromycin | topical |
| Erythromycin (prophylaxis of neonatal chlamydial conjunctivitis) | ophthalmic |
| Erythromycin Ethylsuccinate/Sulfisoxazole | |
| Esmolol and its salts | |
| Estazolam | |
| Estradiol and its salts | |
| Estramustine and its salts | |
| Estrogens / Progestogens | |
| Ethambutol and its salts | |
| Ethinyl Estradiol | |
| Etidronic Acid and its salts | |
| Etidronate Disodium / Calcium Carbonate | |
| Etodolac | |
| Etoposide and its salts | |
| Evening Primrose Oil (except as source for essential fatty acids) | |
| Famciclovir | |
| Famotidine and its salts | |
| Fat Emulsion (Total Parenteral Nutrition Products) | |
| Felodipine and its salts | |
| Fenfluramine and its salts | |
| Fenofibrate | |
| Fenoterol and its salts | |
| Fentanyl and its salts | |
| Fenticonazole | |
| Ferulic Acid | |
| Fexofenadine and its salts | |
| Finasteride | |
| Flecainide and its salts | |
| Fleroxacin | |
| Floctafenine | |
| Fluconazole | |
| Flucytosine | |
| Fludarabine and its salts | |
| Fludrocortisone and its salts | |
| Flumazenil | |
| Flumethasone / Iodochlorohydroxyquin | |
| Flunarizine and its salts | |
| Flunisolide and its salts | |
| Fluocinolone and its salts | |
| Fluoride and its salts | |
| Fluoride and its salts (for osteoporosis, otospongiosis and the treatment and prevention of gingivitis and plaque) | chewing gum |
| Fluorometholone and its salts | |
| Fluorouracil | |
| Fluoxetine and its salts | |
| Flupenthixol and its salts | |
| Fluphenazine enanthate | |
| Fluphenazine decanoate | |
| Flurazepam and its salts | |
| Flurbiprofen and its salts | |
| Flutamide | |
| Fluticasone and its salts | |
| Fluvastatin and its salts | |
| Fluvoxamine and its salts | |
| Formestane | |
| Formoterol and its salts | |
| Foscarnet and its salts | |
| Fosinopril and its salts | |
| Fosphenytoin and its salts | |
| Furosemide | |
| Fusidic acid | |
| Gabapentine | |
| Gadodiamide | |
| Gadolinium | |
| Gadopentetate Dimeglumine | |
| Gadoteridol | |
| Galactose | |
| Galactose/Palmitic Acid | |
| Gallamine and its salts | |
| Gallium Nitrate and its salts | |
| Gamma Amino Butyric Acid (GABA)8 | |
| Gamma Hydroxybutyric Acid (GHB)9 | |
| Gamma Oryzanol | |
| Ganciclovir and its salts | |
| Gemcitabine and its salts | |
| Gemfibrozil | |
| Gentamicin Sulphate | injection |
| Germanium | |
| Gestonorone Caproate | |
| Ginseng (except as per THM Policy)7 | |
| Ginseng/Guarana/Bee pollen (except as per THM Policy)7 | |
| Glatiramer and its salts | |
| Gliclazide | |
| Glucomannan1 | |
| Glucosamine3 | |
| Glyburide | |
| Glycopyrrolate | |
| Gonadorelin and its salts | |
| Goserelin and its salts | |
| Gotu-Kola (see Centella)4 | |
| Granisetron and its salts | |
| Grepafloxacin and its salts | |
| Griseofulvin | ultramicrosize tablet preparation |
| Halcinonide | |
| Halobetasol and its salts | |
| Halofantrine and its salts | |
| Haloperidol and its salts | |
| Haloprogin | |
| Halothane | |
| Heparin | topical |
| Hyaluronidase | |
| Hydralazine and its salts | injection |
| Hydrochlorothiazide (in combination) | |
| Hydrocodone | oral modified release preparation |
| Hydrocortisone | rectal foam |
| Hydrocortisone - 17 - Valerate | topical |
| Hydrocortisone / Allantoin | topical |
| Hydrocortisone / Pramoxine | rectal foam |
| Hydrocortisone / Urea | topical |
| Hydromorphone and its salts | modified release preparations, injection, immediate release spheroids |
| Hydroquinone / Retinoic Acid | topical |
| Hydroxychloroquine Sulfate | |
| Hydroxycitric Acid | |
| Hydroxyurea | |
| Hyoscine Butylbromide | |
| Ibandronate | |
| Ibuprofen | |
| Idarubicin and its salts | |
| Imipramine and its salts | injection |
| Imiquimod | |
| Indapamide Hemihydrate | |
| Indinavir and its salts | |
| Indomethacin | |
| Iodixanol | |
| Iodoquinol | |
| Iohexol | |
| Iopamidol | |
| Iopentol | |
| Iopromide | |
| Iothalamate Meglumine | |
| Iotrolan | |
| Ioversol | |
| Ipratropium and its salts | |
| Irbesartan | |
| Irinotecal and its salts | |
| Iron Dextran | |
| Isoflurane | |
| Isoproterenol and its salts | oral inhalation |
| Isosorbide Dinitrate | |
| Isosorbide-5 Mononitrate | |
| Isotretinoin | |
| Isradipine | |
| Itraconazole | |
| Kava (except as homeopathic preparation and as per THM policy)7 | |
| Ketamine and its salts | |
| Ketazolam | |
| Ketoconazole | |
| Ketoprofen and its salts | |
| Ketorolac and its salts | |
| Ketotifen and its salts | |
| Khat (Kat, Chat - Catha Edulis, Cathenone) | |
| Kojic Acid | |
| Kola Nitida (except as per THM Policy)7 | |
| Labetalol and its salts | |
| Lamotrigine | |
| Lansoprazole | |
| Latanoprost | |
| Letrozole and its salts | |
| Leucovorin and its salts | |
| Leuprolide and its salts | |
| Levamisole and its salts | |
| Levobunolol and its salts | |
| Levocabastine and its salts | |
| Levocarnitine2 | |
| Levodopa and its salts | |
| Levofloxacin | |
| Levonorgestrel | |
| Levorphanol | |
| Lidocaine and its salts (antiarrhythmic agent) | |
| Lidocaine / Prilocaine | |
| Lidocaine HCl / Dextrose 5% (antiarrhythmic agent) | |
| Lidocaine HCl/ Norepinephrine Bitartrate | |
| Lincomycin and its salts | |
| Liothyronine and its salts | |
| Lisinopril and its salts | |
| Lithium and its salts | |
| Lodoxamide Tromethamine | |
| Lomefloxacin and its salts | |
| Loperamide and its salts | |
| Loracarbef | |
| Loratidine | |
| Loratidine / Pseudoephedrine | |
| Lorazepam | |
| Losartan and its salts | |
| Lovastatin | |
| Loxapine and its salts | |
| Mafenide and its salts | |
| Magnesium Pyrrolidone | |
| Malathion | |
| Maprotiline and its salts | |
| Mebendazole | |
| Meclofenamic Acid and its salts | |
| Medroxyprogesterone Acetate | |
| Mefenamic Acid and its salts | |
| Mefloquine and its salts | |
| Megestrol and its salts | |
| Melatonin | |
| Melatonin/Vitamin E | |
| Melphalan and its salts | |
| Mercaptopurine | |
| Meropenem | |
| Mesalamine | |
| Mesna | |
| Metaproterenol and its salts | |
| Metformin and its salts | |
| Methadone | |
| Methazolamide | |
| Methenamine | |
| Methenamine/Benzoic Acid/ Sodium Salicylate | |
| Methimazole | |
| Methotrexate and its salts | |
| Methoxsalen | |
| Methyl Salicylate | spray |
| Methyldopate Hydrochloride | injection |
| Methylprednisolone and its salts | tablet, topical, injection |
| Methylprednisolone and its salts | |
| Metoclopramide and its salts | |
| Metolazone | |
| Metoprolol and its salts | |
| Metrizamide | |
| Metronidazole and its salts | enema, vaginal gel, injection, topical |
| Mexiletine and its salts | |
| Miconazole and its salts | |
| Midazolam and its salts | |
| Midodrine and its salts | |
| Miglitol | |
| Milrinone and its salts | |
| Minocycline and its salts | |
| Minoxidil | |
| Misoprostol | |
| Mitomycin and its salts | |
| Mitoxantrone and its salts | |
| Mivacurium and its salts | |
| Moclobemide | |
| Mometasone Furoate | |
| Montelukast and its salts | |
| Morphine Sulphate | modified release preparations, epidural |
| Mupirocin | |
| Mycophenolate Mofetil | |
| Nabumetone | |
| Nadroparin and its salts | |
| Nadolol and its salts | |
| Nafarelin and its salts | |
| Nafcillin and its salts | |
| Naftifine and its salts | |
| Nalbuphine and its salts | |
| Nalidixic Acid | |
| Nalmefene and its salts | |
| Naloxone and its salts | |
| Naltrexone and its salts | |
| Nandrolone and its salts | |
| Naproxen and its salts | |
| Naratriptan and its salts | |
| Nedocromil and its salts | |
| Nelfinavir and its salts | |
| Neomycin / Polymyxin B | sterile irrigation |
| Nevirapine | |
| Nicardipine and its salts | |
| Niclosamide | |
| Nicotinamide (except as vitamin supplement) | |
| Nicotine | patch, gum |
| Nifedipine | |
| Nilutamide | |
| Nimodipine | |
| Nitrazepam | |
| Nitrofurantoin macrocrystals | |
| Nitroglycerin | oral modified release, patch, ointment, injection, spray |
| Nizatidine | |
| Nonoxynol-9 (HIV claim) | |
| Norfloxacin | |
| Nortriptyline and its salts | |
| Nylidrin and its salts | |
| Nystatin/Zinc Oxide | |
| Octacosanol | |
| Octreotide | |
| Octyl Methoxycinnamate / Oxybenzone / Hydrocortisone | |
| Ofloxacin | |
| Olanzapine | |
| Olopatadine and its salts | |
| Olsalazine and its salts | |
| Omega-3 Fatty Acids, EPA and DHA6 | |
| Omeprazole | |
| Ondansetron and its salts | |
| Oral Contraceptives | |
| Orciprenaline and its salts | |
| Oxacillin and its salts | |
| Oxaprozin | |
| Oxazepam | |
| Oxiconazole and its salts | |
| Oxybutynin and its salts | |
| Oxycodone and its salts (as a single active ingredient) | |
| Oxymetholone | |
| Paclitaxel | |
| Pamidronic Acid and its salts | |
| Pancuronium and its salts | |
| Pangamic Acid and its salts1 | |
| Pantoprazole and its salts | |
| Papain | |
| Papaverine and its salts | topical |
| Papaverine and its salts | |
| Paroxetine and its salts | |
| Pau D'Arco (Taheebo Tea) (except as per THM policy) | |
| Penciclovir | |
| Penicillamine | |
| Pentamidine and its salts | |
| Pentastarch | |
| Pentazocine and its salts | |
| Pentosan Polysulfate Sodium | |
| Pentostatin and its salts | |
| Pentoxifylline and its salts | |
| Peppermint Oil | enteric coated capsules |
| Pergolide and its salts | |
| Pericyazine | |
| Perindopril and its salts | |
| Permethrin | |
| Phentermine and its salts | |
| Phenylbutazone | injection |
| Phenylephrine and its salts /Oxymetazoline and its salts | |
| Phenylpropanolamine and its salts (as appetite suppressant) | |
| Phenytoin and its salts | oral |
| Phenytoin and its salts | |
| Picolinates | |
| Pilocarpine and its salts | tablets |
| Pilocarpine and its salts | |
| Pimozide | |
| Pinaverium and its salts | |
| Pindolol and its salts | |
| Piperacillin and its salts | |
| Pipotiazine and its salts | |
| Pirbuterol and its salts | |
| Piroxicam and its salts | |
| Plant Sterols | |
| Podofilox | |
| Podophyllotoxin | |
| Polynicotinates | |
| Porfimer and its salts | |
| Potassium Citrate | |
| Potassium Fluoride (except as oral mineral supplement) | |
| Pramipexole | |
| Pravastatin and its salts | |
| Praziquantel | |
| Prazosin and its salts | |
| Prednicarbate | |
| Prednisolone and its salts | oral syrup, injection |
| Prednisolone / Gentamicin | ophthalmic |
| Prednisone | oral solution |
| Prilocaine and its salts | |
| Probucol | |
| Procainamide and its salts | |
| Procarbazine and its salts | |
| Procaterol and its salts | |
| Prochlorperizine Edisylate | |
| Progesterone | topical, capsules |
| Propafenone and its salts | |
| Propofol | |
| Propolis (for Herpes) | |
| Propoxyphene and its salts | |
| Propranolol and its salts | |
| Pyrazinamide | |
| Pyridostigmine Bromide | tablet 30mg or any strength with nerve gas antidote claim, oral modified release tablet, injection |
| Pyrimethamine | |
| Quetiapine and its salts | |
| Quinacrine and its salts | |
| Quinapril and its salts | |
| Quinidine Bisulfate | |
| Quinidine Gluconate | oral modified release preparation, injection |
| Raloxifene and its salts | |
| Raltitrexed and its salts | |
| Ramipril and its salts | |
| Ranitidine and its salts | |
| Remifentanil and its salts | |
| Retinoic Acid | |
| Reviparin and its salts | |
| Ribavirin | |
| Ribavirin | |
| Rifampin | |
| Rifampin / Isoniazid / Pyrazinamide | |
| Risperidone | |
| Ritonavir and its salts | |
| Rocuronium and its salts | |
| Ropinirole and its salts | |
| Ropivacaine and its salts | |
| Salbutamol and its salts | |
| Salcatonin | |
| Salicylic Acid/Corticosteroids | |
| Salsalate | |
| Sanguinarine (as antiplaque agent) | |
| Scopolamine HCl / Dihydroergotamine / Barbital / Phenobarbital / Butalbital Sodium | |
| Selegiline and its salts | |
| Selenious Acid | |
| Selenomethionine | |
| Sermorelin and its salts | |
| Sertraline and its salts | |
| Sevoflurane | |
| Silicon (except as mineral supplement) | |
| Silver Nitrate | topical ointment |
| Silver Sulfadiazine | |
| Simvastatin and its salts | |
| Sodium Nitroprusside | |
| Sotalol and its salts | |
| Spectinomycin | |
| Spironolactone | |
| Squalene | |
| Stannous Fluoride (for gingivitis/plaque) | |
| Stanozolol | |
| Streptokinase | |
| Sucralfate | |
| Sufentanil and its salts | |
| Sulbactam/Ampicillin | |
| Sulfadoxine | |
| Sulfamethoxazole/Trimethoprim | |
| Sulfasalazine | |
| Sulfinpyrazone | |
| Sulindac | |
| Sumatriptan and its salts | |
| Superoxide Dismutase (SOD) | |
| Tamoxifen and its salts | |
| Tamsulosin and its salts | |
| Tazarotene and its salts | |
| Temazepam | |
| Tenoxicam | |
| Terazosine and its salts | |
| Terbinafine and its salts | |
| Terconazole | |
| Terfenadine | |
| Terlipressin and its salts | |
| Testosterone and its salts | transdermal, oral |
| Tetracycline and its salts | dental floss |
| Theophylline | oral modified release preparation |
| Thiabendazole | |
| Tiaprofenic Acid and its salts | |
| Ticarcillin and its salts | |
| Ticlopidine and its salts | |
| Tiludronate and its salts | |
| Timolol and its salts | |
| Tinzaparin and its salts | |
| Tioconazole | |
| Tixocortol Pivalate | |
| Tizanidine and its salts | |
| Tobramycin and its salts | |
| Tolbutamide | |
| Tolcapone | |
| Tolmetin and its salts | |
| Tolonium and its salts | |
| Tolterodine l-tartrate | |
| Topiramate | |
| Topotecan and its salts | |
| Toremiphene and its salts | |
| Torsemide | |
| Trace Elements (Total Parenteral Nutrition Products) | |
| Trandolapril and its salts | |
| Tranexamic Acid | |
| Tranylcypromine Sulfate | |
| Trazodone and its salts | |
| Tretinoin | |
| Triamterene | |
| Triazolam | |
| Trichloroacetic Acid | |
| Trichosanthin | |
| Triclosan | medicinal use in oral cavity |
| Trifluoperazine / Isopropamide | |
| Trifluridine | |
| Triglycerides-Medium chain | injectable |
| Trimebutine and its salts | |
| Trimeprazine and its salts | |
| Trimethoprim | |
| Trimetrexate Glucuronate | |
| Trimipramine and its salts | |
| Troglitazone and its salts | |
| Trovafloxacin and its salts | |
| Tryptophan (L-)2 | |
| Ursodiol | |
| Valproic Acid and its salts | |
| Valsartan | |
| Vancomycin and its salts | |
| Vecuronium and its salts | |
| Venlafaxine and its salts | |
| Verapamil and its salts | |
| Vinblastine and its salts | |
| Vincristine and its salts | |
| Vinorelbine and its salts | |
| Vitamins-Multi (with claim for Total Parenteral Nutrition) | injection |
| Warfarin and its salts (prophylaxis of systemic embolism after myocardial infarction) | |
| Yohimbine (aphrodisiac)4 | |
| Zafirlukast | |
| Zalcitabine and its salts | |
| Zidovudine | |
| Zinc Sulfate Heptahydrate | injection |
| Zolmitriptan | |
| Zolpidem and its salts | |
| Zopiclone | |
| Zuclopenthixol and its salts | |
- In the absence of a therapeutic claim, this substance is not considered to be a drug. This substance is only a new drug when intended as an active ingredient.
- Amino acids present in a protein configuration are not considered to be drugs; only when isolated and are present as single ingredient or in a configuration other than completed protein is the drug/new drug status applicable. Note that L-tryptophan and L-Carnitine are on Schedule F to the Regulations, and thus, products containing these two substances would not be considered to be subject to special measures as per the DIN Enforcement Directiveand the Therapeutic Products Compliance Guide.
- This substance without therapeutic claims would not be considered a drug. It is only a new drug when it is intended as a therapeutic agent.
- This substance is listed on Schedule F and therefore, products containing this substance would not be considered to be subject to special measures as per the Therapeutic Products Compliance Guide and the Interim DIN Enforcement Directive.
- This substance is being regulated as a Schedule G (controlled) drug.
- This substance, an omega-3 fatty acid, is present in fish oil and other food substances. It is to be regarded as a new drug only when intended as a therapeutic agent, when isolated/concentrated and sold as a single ingredient or added to other ingredients. Note that this is not considered to be a product subject to special measures as per the Therapeutic Products Compliance Guide and the Interim DIN Enforcement Directive since this is neither a traditional medicine, homeopathic medicine nor vitamin/mineral substance.
- This substance without therapeutic claim is not considered to be a drug. Products containing this substance with claim(s) would be considered to be subject to special measures unless it meets one of the five criteria as per the DIN Enforcement Directive and the Therapeutic Products Compliance Guide. If the claim(s) is not supported by traditional references as per the Traditional Herbal Medicine Policy or only prescribed claims are supported, the product is considered to be a new drug.
- This is a chemical and is not a substance of botanical origin. There is no known safe use of this substance. It is not acceptable as a non-medicinal ingredient at any level and is a new drug when associated with therapeutic claim(s). Products containing this substance with therapeutic claims would not be considered to be subject to special measures as per the DIN Enforcement Directive and the Therapeutic Products Compliance Guide.
- This substance is on Schedule III of the Controlled Drugs and Substances Act and Regulations.
