ESTABLISHED PRODUCTS
MARCH 2024 UPDATEAPI Name | Proprietary Name | Main Indication | Route, Dosage Form | R&D - Status | US DMF - Status |
---|---|---|---|---|---|
Alprostadil | Muse | Erectile dysfunction | Urethral: Suppository | x | |
Azelaic Acid | Azelex, Finacea | Anti-acne; Rosacea | Topical: Cream, Foam, Gel | x | |
Bimatoprost | Durysta, Latisse, Lumigan | Antiglaucoma Helps eyelash growth | Ophthalmic: Implant - Solution,Drops Topical: Solution,Drops | x | |
Carfilzomib | Kyprolis | Oncologic | Injectable: Powder for IV | x | |
Carprofen | Rimadyl (veterinary) | NSAID | Oral: Caplets, Chewable tablets Injectable: Solution | x | |
Ciclopirox Olamine | Loprox, Penlac | Antifungal | Topical: Cream, Shampoo, Suspension | x | |
Colchicine | Colcrys, Gloperba, Lodoco, Mitigare | Antigout Heart Disease | Oral: Tablets, Capsules, Suspension | x | |
Desmopressin Acetate | DDAVP, Stimate | Antidiuretic Hormone | Oral: Tablets Injectable: IV, Subcutaneous Nasal: Spray | x | |
Dexlansoprazole | Dexilant | Anti-ulcer | Oral: DR Capsules | x | |
Diclofenac Epolamine | Flector, Licart | Anti-rheumatic | Topical: Transdermal Patches | x | |
Diclofenac Potassium | Cambia, Zipsor | NSAID | Oral: Powder for solution, Soft Gel Capsules, Tablets | x | |
Diclofenac Sodium | Voltaren - Arthrotec- Pennsaid | NSAID | Oral: DR Tablets; ER Tablets Ophthalmic: Solution Topical: Gel; Solution | x | |
Difluprednate | Durezol | Corticosteroid | Ophthalmic: Emulsion | x | |
Docetaxel | Taxotere | Oncologic | Injectable: IV solution | x | |
Droxidopa | Northera | Cardiovascular | Oral: Capsules | x | |
Efinaconazole | Jublia | Antifungal | Topical: Solution | x | |
Etodolac | Lodine - Lodine XL | Anti-rheumatic | Oral: Tablets, ER Tablets, Capsules | x | |
Everolimus | Afinitor, Afinitor Disperz, Zortress | Oncologic; Immuno suppressant | Oral: Tablets, Tablets for Suspension | x | |
Fesoterodine Fumarate | Toviaz | Urinary Incontinence | Oral: ER Tablets | x | |
Flecainide Acetate | Tambocor | Anti-arrhythmic | Oral: Tablets | x | |
Ganirelix Acetate | Antagon | Infertility | Injectable: Pre-filled Syringe | x | |
Glipizide | Glucotrol, Glucotrol XL, Metaglip | Diabetes | Oral: Tablets, ER Tablets | x | |
Icatibant Acetate | Firazyr | Angioedema | Injectable: Pre-filled Syringe (subcutaneous) | x | |
Icosapent Ethyl (EPA) | Vascepa | Hyper triglyceridemia | Oral: Soft Gel Capsules | x | |
Imiquimod | Zyclara | Keratosis | Topical: Cream | x | |
Indomethacin | Indocin | Pain Treatment | Oral: Suspension, Capsules, ER Capsules | x | |
Latanoprost | Xalatan, Iyuzeh, Rocklatan, Xelpros | Glaucoma Treatment | Ophthalmic: Solution; Emulsion | x | |
Lidocaine Base | Lidoderm | Anesthetic | Topical: Ointment, Patch | x | |
Lidocaine HCl | Multiple | Anesthetic | Injectable: Solution Ophthalmic: Gel Oral: Solution Topical: Solution, Jelly | x | |
Loteprednol Etabonate | Alrex, Eysuvis, Inveltys, Lotemax, Lotemax SM | Anti-allergy | Ophthalmic: Gel, Suspension, Ointment | x | |
Lubiprostone | Amitiza | Laxative | Oral: Soft Gel Capsules | x | |
Lurasidone HCl | Latuda | Antipsychotic | Oral: Tablets | x | |
Meloxicam | Mobic, Vivlodex | NSAID | Oral: Tablets, Capsules, Suspension | x | |
1% Misoprostol HPMC | Arthrotec, Cytotec | Antiulcerant | Oral: Tablets, DR Tablets | x | |
Mycophenolate Mofetil | Cellcept | Immuno suppressant | Oral: Tablets, Capsules, Suspension | x | |
Mycophenolate Mofetil HCl | Cellcept | Immuno suppressant | Injectable: IV Infusion | x | |
Mycophenolate Sodium | Myfortic | Immuno suppressant | Oral: DR Tablets | x | |
Nepafenac | Ilevro, Nevanac | NSAID | Ophthalmic: Solution, Suspension | x | |
Obeticholic Acid | Ocaliva | GI Diseases | Oral: Tablets | x | |
Paclitaxel | Abraxane, Taxol | Oncologic | Injectable: IV Solution, Lyophilized Powder for IV | x | |
Paliperidone | Invega | Schizophrenia | Oral: ER Tablets | x | |
Paliperidone Palmitate | Invega Sustenna, Invega Trinza, Invega Hafyera | Schizophrenia | Injectable: ER Suspension (IM) | x | |
Prilocaine Base | Emla, Oraqix | Local Anesthetic | Topical: Cream, Periodontal Gel | x | |
Prilocaine HCl | Citanest, Citanest Forte, Citanest Forte Dental | Local Anesthetic | Injectable: Solution | x | |
Ranolazine | Ranexa, Aspruzyo Sprinle | Antianginal | Oral: ER Tablets, ER Granules (sachets) | x | |
Risperidone | Risperdal, Risperdal Consta, Rykindo, Perseris Kit, Uzedy | Antipsychotic | Oral: Tablets Injectable: Powder for Suspension (IM - subcut.), ER Suspension (prefilled syringe) | x | |
Rivastigmine Base | Exelon | Dementia treatment | Transdermal: Patches | x | |
Roflumilast | Daliresp, Zoryve | COPD - Psoriasis | Oral: Tablets Topical: Cream, Foam | x | |
Rotigotine | Neupro | Parkinson, Restless Leg Syndrome | Transdermal: Patches | x | |
Rufinamide | Banzel | Antiepileptic | Oral: Tablets | x | |
Sirolimus | Rapamune, Fyarro, Hyftor | Immuno suppressant | Oral: Tablets, Solution Injectable: Powder (IV) Topical: Gel | x | |
Solifenacin Succinate | VESicare, VESicare LS | Overreactive bladder and other genitourinary system diseases | Oral: Tablet, Suspension | x | |
Spironolactone | Aldactazide, Aldactone, CaroSpir | Antihypertensive | Oral: Tablets, Suspension | x | |
Tacrolimus | Prograf, Protopic, Astragraf XL | Immuno suppressant (Prograf) Dermatitis (Protropic) | Oral: Capsules, Granules for Suspension, ER Capsules Injectable: Solution (IV) Topical: Ointment | x | |
Tafluprost | Zioptan | Glaucoma Treatment | Ophthalmic: Solution | x | |
Tofacitinib Citrate | Xeljanz, XeljanzXR | Rheumatoid Arthritis | Oral: Tablets, ER Tablets, Solution | x | |
Tolterodine Tartrate | Detrol, Detrol LA | Overactive Bladder | Oral: Tablets, ER Capsules | x |