Details for New Drug Application (NDA): 218204
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NDA 218204 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Alembic, Amphastar Pharm, Apotex Inc, Apothecon, Aspiro, Baxter Hlthcare Corp, Bedford, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Sagent Pharms Inc, Sandoz, Steriscience Speclts, Sun Pharm, Wockhardt, Wockhardt Bio Ag, Chartwell Rx, Epic Pharma Llc, Micro Labs Ltd India, Atnahs Pharma Us, Bionpharma, Hetero Labs Ltd Iii, Leading, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Zydus Lifesciences, and Lupin Ltd, and is included in fifty-six NDAs. It is available from sixty-three suppliers. Additional details are available on the KETOROLAC TROMETHAMINE profile page.
The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 218204
| Tradename: | KETOROLAC TROMETHAMINE |
| Applicant: | Caplin |
| Ingredient: | ketorolac tromethamine |
| Patents: | 0 |
Pharmacology for NDA: 218204
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218204
Suppliers and Packaging for NDA: 218204
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 218204 | ANDA | Caplin Steriles Limited | 65145-138 | 65145-138-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-138-01) / 3 mL in 1 BOTTLE, DROPPER |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 218204 | ANDA | Caplin Steriles Limited | 65145-139 | 65145-139-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-139-01) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Mar 26, 2024 | TE: | AT | RLD: | No | ||||
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