Study Designs
BioPharma Services has completed a wide range of Study Designs for our Sponsors
At BioPharma Services, our Pharmacokinetics experts can provide Bioequivalence Study Designs for a wide variety of medicinal formulations for different purposes and submission agencies. Below are a list of over 300 available study designs of some common Active Pharmaceutical Ingredients (APIs) for your reference.
We also offer consultations and customizations for individual client to ensure that our study design can fulfill all your expectations. If you can not find your APIs on the list, please Contact Us to cover how we can support your clinical trial with our award-winning end-to-end approach which includes protocol development, clinical execution, bioanalysis, scientific regulatory affairs, data management, and medical writing.
Study Designs
| Compound | Formulation | Strength (mg) | Agency | Release Date | Notes |
|---|---|---|---|---|---|
| Acalabrutinib | Capsule | 100 | FDA | Aug 2021 | |
| Acamprosate | Tablet DR | 333 | FDA | Oct 2021 | |
| Acetazolamide | Tablet | 250 | All | Nov 2021 | |
| Afatinib | Tablet | 50 | EMA | Nov 2020 | |
| Albuterol sulfate | Aerosol metered | 0.09 | FDA | Nov 2021 | |
| Alitretinoin | Capsule | 30 | EMA | Aug 2020 | |
| Alvimopan | Capsule | 12 | FDA | Oct 2021 | |
| Ambrisentan/Tadalafil | Tablet | 10/40 | EMA | Dec 2021 | |
| Amlodipine | Tablet | 10 | EMA | July 2022 | |
| Amlodipine/Perindopril/Indapamide | Capsule ER | 10/10/1.5 | EMA | Mar 2022 | 505b2 (New FDC) |
| Amphetamine | Tablet ODT ER | 18.8 | FDA | June 2022 | |
| Amphetamine mixed salts | Capsule ER | 30 | FDA | Sept 2022 | |
| Amphotericin B | Injectable liposomal | 50 | All | June 2022 | |
| Apalutamide | Tablet | 60 | FDA | Aug 2021 | |
| Apixaban | Tablet | 5 | EMA | Apr 2020 | |
| Aprepitant | Capsule | 125 | FDA | July 2020 | |
| Atorvastatin/Ezetimibe | Tablet | 80/10 | EMA | Jan 2023 | |
| Axitinib | Tablet | 5 | All | Dec 2022 | |
| Azelastine/Fluticasone | Spray metered | 0.137/0.05 | All | Jan 2022 | |
| Azilsartan medoxomil | Tablet | 80 | EMA | Aug 2022 | |
| Azilsartan/Chlorthalidone | Tablet | 40/25 | EMA | Nov 2021 | |
| Baricitinib | Tablet | 2 | All | Jan 2022 | |
| Bempedoic Acid | Tablet | 180 | FDA | Jan 2022 | |
| Betamethasone Dipropionate | Cream | 0.5 | EMA | Jan 2020 | PD endpoint |
| Bexarotene | Capsule | 75 | EMA | Apr 2021 | |
| Bisoprolol Fumarate | Tablet | 10 | FDA | June 2021 | |
| Bosentan | Tablet | 125 | TPD | Apr 2022 | |
| Bosutinib | Tablet | 500 | EMA | Dec 2021 | |
| Brivaracetam | Tablet | 100 | All | Mar 2022 | |
| Bromazepam | Tablet | 6 | EMA | Dec 2020 | |
| Budesonide | Capsule ER | 4 | FDA | Jan 2022 | 505b2 (New Strength) |
| Budesonide | Capsule ER | 4 | FDA | May 2022 | |
| Budesonide | Tablet ER | 9 | FDA | Mar 2022 | |
| Budesonide/Formoterol | Powder metered | 0.16/0.0045 | EMA | July 2021 | |
| Budesonide/Formoterol | Powder metered | 0.4/0.012 | TPD | July 2021 | |
| Buprenorphine | Sublingual Tablet | 8 | FDA | Apr 2021 | |
| Buprenorphine/Naloxone | Film | 12/3 | FDA | Sept 2022 | |
| Buprenorphine/Naloxone | Sublingual Tablet | 11.4/2.9 | FDA | Sept 2022 | |
| Bupropion HCL | Tablet ER | 300 | FDA | Nov 2022 | |
| Buproprion/Dextromethorphan | Tablet | 105/45 | All | Feb 2021 | |
| Cannabidiol | Solution | 100 | FDA | Oct 2021 | And EMA |
| Cannabidiol/THC | Buccal Spray | 25/27 | EMA | Oct 2021 | |
| Carbidopa/Levodopa | Tablet | 25/250 | EMA | Dec 2022 | |
| Carglumic Acid | Tablet for suspension | 200 | FDA | Sept 2020 | |
| Cariprazine | Capsule | 1.5 | EMA | Aug 2020 | |
| Chenodeoxycholic acid | Capsule | 250 | EMA | May 2022 | |
| Chlorthalidone | Tablet | 50 | TPD | June 2021 | |
| Cilostazol | Tablet | 100-50 | TPD | Jan 2022 | |
| Ciprofloxacin | Tablet | 750 | EMA | Mar 2022 | |
| Clorazepate Dipotassium | Tablet | 15 | FDA | June 2022 | |
| Colchicine | Tablet | 0.6 | FDA | July 2021 | 505b2 (New Strength) |
| Dapagliflozin/Metformin | Tablet | 10/1000 | EMA | Feb 2020 | |
| Dapagliflozin/Metformin | Tablet | 10/1000 | TPD | Feb 2020 | |
| Dapagliflozin/Sitagliptin | Tablet | 10/100 | EMA | Apr 2021 | |
| Dasatinib | Tablet | 140 | EMA | Oct 2021 | |
| Dasatinib | Tablet | 140 | TPD | Jan 2020 | |
| Dasatinib | Tablet | 100 | FDA | Jan 2020 | |
| Dasatinib | Tablet | 100 | TGA | Jan 2020 | |
| Deferiprone | Tablet | 1000 | FDA | Feb 2022 | For NDA#21825 (tid) |
| Deferiprone | Tablet | 1000 | FDA | Feb 2022 | For NDA#212269 (bid) |
| Desogestrel/Ethinyl Estradiol | Tablet | 0.15/0.02 | EMA | Feb 2022 | |
| Desogestrel/Ethinyl Estradiol | Tablet | 0.15/0.03 | EMA | May 2022 | |
| Dexlansoprazole | Capsule ER | 60 | FDA | Feb 2020 | |
| Dexlansoprazole | Capsule DR | 60 | EMA | Dec 2021 | |
| Dexmethylphenidate HCl | Capsule ER | 40 | FDA | Feb 2022 | |
| Diazoxide | Suspension | 50 mg/mL | FDA | Apr 2020 | |
| Diclofenac diethylamine | Gel | 0.0116 | EMA | Mar 2022 | And TPD |
| Diclofenac sodium | Tablet DR | 25-75 | FDA | Jan 2021 | |
| Dimethyl Fumarate | Capsule DR | 240 | EMA | Nov 2021 | |
| Dimethyl Fumarate | Capsule DR | 240 | FDA | Nov 2021 | |
| Dimethyl Fumarate | Capsule DR | 240 | TPD | Nov 2021 | |
| Diphenhydramine | Suspension injection | 50 mg/mL | FDA | June 2020 | |
| Docusate sodium | Capsule | 100 | MHRA | Jan 2022 | |
| Dofetilide and Mexiletine | Capsule | 0.5/275 | FDA | Oct 2020 | 505b2 (New FDC) |
| Donepezil HCl/Memantine HCl | Capsule ER | 10/28 | FDA | Nov 2021 | |
| Donezepil | Depot | 70-280 | FDA | Apr 2020 | Phase 1 |
| Doxepin | Capsule | 50 | EMA | May 2020 | |
| Duloxetine | Capsule ER | 60 | EMA | Dec 2021 | |
| Edavarone | Suspension | 100 | FDA | Mar 2020 | 505b2 (New formulation) |
| Edavarone | Suspension | 105 | FDA | Oct 2022 | |
| Edoxaban | Tablet | 60 | EMA | May 2022 | |
| Elagolix | Tablet | 200 | EMA | Jan 2021 | |
| Elagolix | Tablet | 200 | FDA | Jan 2021 | |
| Eltrombopag | Tablet | 75 | EMA | July 2020 | |
| Empagliflozin | Tablet | 25 | EMA | Nov 2021 | |
| Empagliflozin/Metformin | Tablet | 12.5/1000 | EMA | Nov 2021 | EMA |
| Emtricitabine tenofovir rilpivirine | Tablet | 200/25/25 | EMA | Sept 2022 | |
| Enalapril | Tablet | 20 | EMA | Feb 2020 | |
| Enoxaparin sodium | Injection solution/Supension | 100 mg/mL | FDA | Dec 2021 | |
| Enzalutamide | Capsule | 80 | All | Jan 2022 | |
| Eplerenone/ Torasemide | Tablet | 50/10 | EMA | Dec 2021 | 505b2 (New FDC) |
| Escitalopram Oxalate | Tablet | 20 | EMA | Dec 2021 | |
| Esomeprazole | Tablet DR | 40 | FDA | Sept 2020 | |
| Estradiol | Film | 0.025mg/24h | FDA | Feb 2021 | Irritation and sensitization |
| Estradiol | Ring | 2 | FDA | Mar 2020 | |
| Estrogen | Cream | 0.625 | FDA | Aug 2021 | |
| Estrogens | Cream | 0.625 | FDA | Aug 2021 | |
| Ethinly Estradiol/ Norethindrone acetate | Tablet | 1/0.5 | All | Feb 2022 | |
| Ethinly Estradiol/ Norethindrone acetate | Tablet | 1/0.5 | All | Feb 2022 | |
| Ethinly Estradiol/ Norethindrone acetate | Tablet | 0.01/1 | FDA | Sept 2021 | |
| Ethinyl estradiol/Norelgestromin | Film | 0.035-0.15/24h | FDA | Aug 2022 | Irritation and sensitization |
| Ethinyl estradiol/Norelgestromin | Film | 0.035-0.15/24h | FDA | Aug 2022 | PK-adhension |
| Ethinyl estradiol/segesterone acetate | Ring | 0.013/0.15 | FDA | June 2022 | |
| Ethinyl estradiol/Segesterone acetate | Ring | 0.013-0.15/24h | FDA | June 2022 | |
| Favipiravir | Tablet | 200 | EMA | Nov 2021 | |
| Ferric Carboxymaltose | Injection solution/Supension | 50mg/mL | FDA | June 2021 | And EMA |
| Finasteride/Tadalafil | Tablet | 5/5 | EMA | Nov 2020 | Drug interaction (mono vs Co-administration) |
| Fingolimod HCl | Capsule | 0.5 | All | July 2021 | |
| Flucytosine | Capsule | 500 | FDA | July 2021 | And EMA |
| Fluticasone/Umeclidinium/Vilanterol | Powder metered | 200/62.5/25 mcg | FDA | Feb 2022 | PK endpoint design |
| Fluticasone/Vilanterol | Powder metered | 0.2/0.025 | FDA | Sept 2022 | PK endpoint design |
| Formoterol Fumarate | Injection solution/Supension | 12 mcg | FDA | Feb 2022 | PK profiling |
| Fulvestrant | Injection solution/Supension | 250mg/5mL | FDA | Mar 2020 | Per request only |
| Gabapentin | Capsule | 400 | EMA | Mar 2021 | |
| Gabapentin | Capsule | 400 | FDA | Mar 2021 | |
| Gilteritinib | Tablet | 40 | All | Dec 2021 | |
| Glycopyrronium bromide | Powder metered | 44 mcg | EMA | Sept 2022 | |
| Gonadotropin | Injection | 75 IU | EMA | Jan 2021 | |
| Guaifenesin/Dextromethorphan | Liquid | 100/5 | FDA | Nov 2022 | |
| Guanfacine HCl | Tablet ER | 1-4 | All | Nov 2021 | |
| Hydrocodone bitartrate | Tablet ER | 20 | FDA | Nov 2021 | PK intact form |
| Hydrocortisone | Solution | 100 mg/6mL | FDA | Dec 2021 | for enema |
| Hydroxyurea | Capsule | 500 | TPD | Sept 2021 | |
| Ibrutinib | Tablet | 560 | EMA | Dec 2022 | |
| Ibrutinib | Tablet | 560 | FDA | Dec 2022 | |
| Ibuprofen | Tablet ER | 600 | TPD | Jan 2022 | |
| Ibuprofen | Tablet | 200 | FDA | Sept 2021 | |
| Ibuprofen Lysine | Tablet | 684 | EMA | Apr 2021 | |
| Imatinib | Tablet | 400 | FDA | Feb 2022 | And EMA |
| Indacaterol/Glycopyrronium | Powder metered | 85/43 mcg | EMA | Aug 2022 | |
| Indapamide | Tablet ER | 1.5 | EMA | Jan 2022 | |
| Indapamide/Ramipril | Tablet ER | 1.5/10 mg | EMA | Sept 2022 | |
| Indomethacin | Suppository | 50 | FDA | May 2020 | |
| Inosine Pranobex | Tablet | 500 | EMA | Oct 2021 | |
| Ipratropium Bromide | Aerosol metered | 0.021 | FDA | Sept 2022 | |
| Isotretinoin | Capsule | 40 | All | Dec 2021 | |
| Ivacaftor | Tablet | 150 | All | May 2021 | |
| Ivermectin | Tablet | 3 | FDA | Oct 2022 | |
| Ivosidenib | Tablet | 250 | FDA | Sept 2020 | |
| Lacosamide | Suspension | 10mg/mL | EMA | Apr 2020 | Syrup |
| Lanreotide | Injection solution/Supension | 120 | EMA | Nov 2020 | |
| Lanreotide | Injection solution/Supension | 120 | EMA | Mar 2021 | Multiple dose |
| Lanthanum Carbonate | Tablet chewable | 1000 | FDA | July 2021 | PD endpoint |
| Lenalidomide | Tablet | 25 | All | July 2020 | |
| Letrozole | Tablet | 2.5 | EMA | May 2022 | |
| Leuprolide Acetate | Injection suspension ER | 7.5 | FDA | Feb | And EMA |
| Levetiracetam | Tablet ER | 750 | FDA | Oct 2022 | |
| Carbidopa/Levodopa | Tablet ER | 50/200 | FDA | May 2021 | |
| Carbidopa/Levodopa | Tablet ER | 87.5/350 | FDA | June 2021 | Alcohol interaction |
| Levofloxacin | Tablet | 500 | EMA | Jan 2021 | |
| Levothyroxine | Tablet | 0.3 | TPD | Feb 2020 | |
| Levothyroxine Sodium | Sublingual Tablet | 0.3 | FDA | May 2022 | 505b2 (New formulation) |
| Linagliptin | Tablet | 5 | EMA | Mar 2022 | |
| Linagliptin/Metformin | Tablet | 2.5/1000 | EMA | Mar 2022 | And TPD |
| Liothyronine | Tablet | 0.05 | All | Dec 2021 | |
| Liraglutide Recombinant | Injection | 6mg/mL | EMA | Jan 2022 | |
| Liraglutide Recombinant | Injection | 6mg/mL | FDA | Jan 2022 | |
| Liraglutide Recombinant | Injection | 6mg/mL | TPD | Sept 2021 | |
| Lisdexamfetamine | Capsule | 70 | All | Jan 2022 | |
| Lisdexamfetamine | Tablet chewable | 60 | FDA | May 2022 | |
| Lisdexamfetamine | Solution | 10 | FDA | Apr 2021 | 505b2 (New formulation) |
| Lofexidine | Tablet | 0.18 | FDA | Dec 2020 | |
| Loperamide | Capsule | 2 | TPD | Mar 2022 | |
| Loprazolam | Capsule | 2 | Other | June 2022 | For South Africa |
| Lurasidone | Tablet | 37 | EMA | Apr 2021 | |
| Macitentan | Tablet | 10 | EMA | Jan 2020 | |
| Macitentan | Tablet | 10 | TPD | June 2021 | |
| Macitentan/Tadalafil | Tablet | 10/40 | EMA | Apr 2022 | And TPD |
| Mebeverine HCl | Capsule ER | 200 | All | Mar 2022 | |
| Meloxicam | Injection | 30 | FDA | June 2021 | |
| Mercaptopurine | Suspension | 20 | FDA | Feb 2022 | |
| Mesalamine | Capsule ER | 500 | FDA | Apr 2022 | |
| Mesalamine | Capsule ER | 800 | FDA | Oct 2022 | |
| Mesalamine | Capsule ER | 1200 | FDA | Nov 2021 | |
| Mesalamine | Tablet ER | 1000 | EMA | Mar 2020 | |
| Mesalamine | Capsule ER | 375 | FDA | July 2021 | |
| Mesalamine | Tablet ER | 1200 | EMA | Nov 2021 | |
| Metformin | Tablet | 1000 | All | Jan 2022 | |
| Metformin | Tablet ER | 1000 | All | Dec 2020 | |
| Metformin/Empagliflozin/Linagliptin | Tablet | 1000/25/5 | FDA | Aug 2022 | BE for FDA and 505b2 for EMA (new FDC) |
| Methylnaltrexone Bromide | Tablet | 150 | FDA | May 2021 | |
| Methylphenidate | Tablet chewable ER | 40 | FDA | Dec 2020 | |
| Methylphenidate | Tablet for suspension | 25mg/5mL | FDA | Dec 2020 | |
| Methylphenidate | Capsule ER | 60 | FDA | Jan 2023 | |
| Metolazone | Tablet | 10 | FDA | June 2021 | |
| Metoprolol succinate | Tablet ER | 200 | FDA | Nov 2020 | |
| Mianserin | Tablet | 60 | EMA | Dec 2020 | |
| Midostaurin | Capsule | 25 | All | Dec 2020 | |
| Misoprostol | Tablet | 0.2 | FDA | June 2020 | |
| Mometasone | Spray | 0.05 | FDA | June 2020 | |
| Mometasone | Ointment | 0.001 | TPD | July 2020 | PD endpoint |
| Morphine | Tablet | 30 | FDA | June 2020 | |
| Moxidectin | Tablet | 2 | FDA | Jan 2022 | |
| Mycophenolate Mofetil | Suspension | 200mg/mL | FDA | Oct 2021 | |
| N-Acetylcystein | Tablet effervescent | 600 | Other | May 2020 | for NMPA |
| Nalmefene | Tablet | 18 | EMA | Nov 2020 | |
| Naloxone | Injection | 0.4mg/mL | FDA | June 2020 | |
| Nebivolol | Tablet | 20 | FDA | May 2021 | |
| Nebivolol/ Hydrochlorothiazide | Tablet | 5/12.5 | EMA | Mar 2022 | |
| Neratinib | Tablet | 240 | FDA | Aug 2021 | |
| Nilotinib | Capsule | 200 | EMA | Sept 2022 | |
| Nilotinib | Capsule | 200 | FDA | Sept 2022 | |
| Nimodipine | Capsule | 30 | FDA | Sept 2021 | |
| Nimodipine | Injection solution/Supension | 0.0002 | FDA | Oct 2022 | 505b2 (New formulation) |
| Nirmatrelvir/Ritonavir | Tablet | 150/100 | WHO | Sept 2022 | |
| Nitrofurantoin | Suspension | 25mg/5mL | FDA | Sept 2021 | |
| Nortriptyline | Tablet | 75 | All | July 2021 | and for Capsule |
| Obeticholic acid | Tablet | 10 | EMA | Mar 2022 | And TPD |
| Obeticholic acid | Tablet | 10 | FDA | Mar 2022 | |
| Olanzapine | Suspension | 5 | FDA | Dec 2021 | 505b2 (New formulation) |
| Orlistat | Capsule | 60 | FDA | Aug 2021 | PD endpoint |
| Oseltamivir | Capsule | 75 | EMA | June 2020 | |
| Otilonium bromide | Tablet | 40 | EMA | Dec 2021 | |
| Oxycodone | Tablet ER | 30 | FDA | Mar 2022 | Nasal PK |
| Ozanimod | Capsule | 0.92 | FDA | Apr 2022 | and EMA |
| Palbociclib | Capsule | 125 | EMA | Sept 2021 | |
| Palbociclib | Tablet | 125 | EMA | Sept 2021 | |
| Palbociclib | Tablet ER | 125 | EMA | Oct 2021 | DDI study with PPI |
| Palbociclib | Tablet | 125 | FDA | Dec 2020 | |
| Palbociclib/Letrozole | Tablet | 125/2.5 | EMA | Apr 2022 | 505b2 (new FDC) - PPI Pre-treatment |
| Paliperidone | Tablet ER | 6 | FDA | Dec 2021 | |
| Pazopanib | Tablet | 400 | All | July 2022 | |
| Perampanel | Pellet | 12 | All | Dec 2020 | 505b2 (New formulation) |
| Perindopril arginine/ Indapamide | Tablet | 10/2.5 | All | Dec 2021 | |
| Perindopril arginine/Amlodipine | Tablet | 10/10 | NMPA | Oct 2021 | |
| Phytonadione | Injection | 10mg/mL | FDA | Aug 2022 | |
| Phytonadione | Injection | 10mg/mL | FDA | Aug 2022 | 505b2 (New Strength) |
| Pitavastatin/Ezetimibe | Tablet | 4-10 | EMA | Jan 2021 | 505b2 (New FDC) |
| Pitolisant | Tablet | 17.8 | FDA | Feb 2022 | |
| Pomalidomide | Capsule | 4 | EMA | Aug 2022 | |
| Pomalidomide | Capsule | 4 | FDA | Nov 2022 | |
| Pomalidomide | Capsule | 4 | TPD | Nov 2022 | |
| Ponatinib | Tablet | 45 | EMA | Jan 2022 | |
| Ponatinib | Tablet | 45 | FDA | Jan 2022 | |
| Prednisolone | Tablet | 25 | EMA | Mar 2022 | |
| Prednisone | Tablet ER | 5 | FDA | June 2020 | |
| Pregabalin | Tablet ER | 330 | FDA | Dec 2019 | |
| Pregabalin | Cream | 0.1 | EMA | Aug 2022 | Phase 1 |
| Progesterone | Capsule | 200 | EMA | July 2021 | |
| Progesterone | Capsule | 200 | All | Sept 2021 | |
| Propofol | Injection | 0.01 | FDA | Mar 2021 | 505b2 (New formulation) |
| Pyrantel Embonate | Tablet chewable | 250 | EMA | June 2020 | |
| Pyridostigmine Bromide | Tablet ER | 275 | FDA | July 2021 | Phase 1 |
| Ramipril | Tablet | 10 | EMA | Oct 2022 | |
| Ramipril/Indapamide | Tablet | 10/2.5 | EMA | Nov 2021 | 505b2 (new FDC) |
| Ramipril/Indapamide | Tablet ER | 10/1.5 | EMA | Sept 2022 | 505b2 (new FDC) |
| Ranolazine | Tablet ER | 750 | EMA | May 2021 | |
| Regorafenib | Tablet | 40 | EMA | Apr 2021 | |
| Ribociclib | Tablet | 200 | FDA | Dec 2020 | |
| Rifaximin | Tablet | 550 | FDA | May 2020 | |
| Rifaximin | Tablet | 200 | EMA | May 2020 | |
| Ritonavir | Tablet | 100 | WHO | July 2022 | |
| Rivaroxaban | Tablet | 20 | All | Nov 2020 | |
| Rivaroxaban | Tablet | 20 | EMA | Apr 2022 | Crushed with apple sauce |
| Rosuvastatin/Candesartan | Tablet | 20/32 | EMA | Jan 2022 | 505b2 (New formulation) |
| Rotigotine | Patch | 2mg/24h | EMA | Aug 2020 | PK-adhension |
| Rotigotine | Patch | 2mg/24h | EMA | Aug 2020 | Irritation and sensitization |
| Roxadustat | Capsule | 100 | NMPA | June 2020 | |
| Rupatadine | Tablet | 10 | TPD | Nov 2022 | |
| Ruxolitinib | Tablet | 20 | EMA | Nov 2022 | |
| Ruxolitinib | Tablet | 20 | TPD | Nov 2022 | |
| Ruxolitinib | Tablet ER | 50 | FDA | Nov 2022 | 505b2 (New formulation) |
| Sacubitril/Valsartan | Tablet | 97/103 | All | Feb 2022 | |
| Selegiline | Patch | 6mg/24h | FDA | Dec 2020 | PK-adhension |
| Semaglutide | Injection solution/Supension | 1 | EMA | Mar 2021 | |
| Semaglutide | Tablet | 14 | FDA | Sept 2021 | |
| Sertraline | Tablet | 200 | EMA | Nov 2020 | 505b2 (New Strength) |
| Siponimod | Tablet | 2 | FDA | Oct 2021 | |
| Sitagliptin | Tablet | 100 | All | Oct 2021 | |
| Sitagliptin/Metformin | Tablet | 50/1000 | All | Sept 2022 | |
| Sitagliptin/Metformin | Tablet ER | 100/1000 | All | Aug 2022 | |
| Sodium Oxybate | Powder for suspension | 9 | FDA | Mar 2021 | 505b2 (New formulation) |
| Sofosbuvir | Tablet | 400 | All | Oct 2021 | |
| Solifenacin succinate/Tamsulosin hydrochloride | Tablet ER | 6/0.4 | EMA | July 2021 | |
| Sumatriptan | Tablet | 100 | EMA | Jan 2021 | |
| Sunitinib | Tablet | 50 | All | July 2021 | |
| Suvorexant | Tablet | 20 | FDA | Feb 2022 | |
| Tacrolimus | Capsule | 5 | FDA | Jan 2022 | |
| Tacrolimus | Capsule ER | 4 | FDA | Jan 2022 | |
| Tadalafil | Tablet ODT | 20 | EMA | June 2022 | |
| Tafamidis | Capsule | 61 | FDA | May 2021 | |
| Tapentadol | Tablet ER | 250 | All | Feb 2022 | |
| Teduglutide | Injection powder | 5 | EMA | Mar 2021 | |
| Telmisartan/Indapamide | Tablet ER | 80/1.5 | EMA | May 2021 | |
| Tenofovir disoproxil fumarate | Tablet | 300 | TPD | Sept 2021 | |
| Ticagrelor | Tablet | 90 | EMA | May 2021 | |
| Timonacic Acid | Tablet | 100 | EMA | Apr 2022 | |
| Timonacic Acid | Tablet | 100 | EMA | May 2022 | Dose proportional |
| Tiotropium Bromide | Powder metered | 2.5 mcg | All | Sept 2022 | PK endpoint design |
| Tofacitinib | Tablet ER | 22 | FDA | Feb 2022 | |
| Tofacitinib | Tablet | 10 | EMA | Aug 2021 | |
| Tolvaptan | Tablet | 90 | All | Dec 2020 | |
| Topiramate | Capsule ER | 200 | FDA | Oct 2020 | |
| Tramadol/Dexketoprofen | Tablet | 75/25 | EMA | Jan 2022 | |
| Trametinib | Tablet | 2 | FDA | June 2022 | and EMA |
| Tranylcypromine | Tablet | 10 | EMA | Mar 2021 | |
| Trazodone | Tablet ER | 150 | EMA | Mar 2021 | |
| Triazolam | Tablet | 0.25 | All | Feb 2022 | |
| Ulipristal Acetate | Tablet | 30 | EMA | Sept 2022 | |
| Upadacitinib | Tablet ER | 45 | FDA | June 2022 | |
| Ursodiol | Tablet | 500 | FDA | May 2020 | |
| Valsartan/Hydrochlorothiazide | Tablet | 320/25 | EMA | Mar 2022 | |
| Varenicline | Tablet ER | 2 | EMA | May 2020 | 505b2 (New Strength) |
| Venetoclax | Tablet | 100 | FDA | Feb 2022 | |
| Venetoclax | Tablet | 100 | EMA | Feb 2022 | |
| Venetoclax | Tablet | 400 | FDA | Mar 2022 | and EMA |
| Verapamil | Tablet ER | 360 | FDA | Jan 2023 | |
| Verapamil | Tablet ER | 300 | FDA | Nov 2022 | |
| Vigabatrin | Tablet | 500 | FDA | Mar 2021 | |
| Vildagliptin/Metformin | Tablet | 50/1000 | EMA | Apr 2020 | |
| Vismodegib | Capsule | 150 | EMA | Dec 2022 | |
| Voclosporin | Capsule | 7.9 | FDA | Sept 2022 | |
| Vortioxetine | Tablet | 20 | EMA | Nov 2021 | |
| Vortioxetine | Tablet | 20 | TPD | May 2020 | |
| Zolpidem Tartrate | Tablet | 12.5 | FDA | Feb 2020 | 505b2 (pilot) |
| Zonisamide | Tablet | 300 | EMA | Apr 2020 | 505b2 (New formulation) |
Regulatory Agencies
Abbreviation Full name Country /Organization of origin FDA U.S. Food and Drug Administration United States EMA European Medicines Agency European Union TPD Pharmaceutical Drugs Directorate (formerly the Therapeutic Products Directorate) Canada TGA Therapeutic Goods Administration Australia NMPA National Medical Products Administration China ANVISA The Brazilian Health Regulatory Agency Brazil GCC Gulf Cooperation Council The Arab States of the Gulf ASEAN Association of Southeast Asian Nations Southeast Asian Countries WHO World Health Organization World Health Organization
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