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Details for New Drug Application (NDA): 076209
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NDA 076209 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz Inc, Sun Pharm, West-ward Pharms Int, Wockhardt, Akorn, Aurobindo Pharma Ltd, Micro Labs Ltd India, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, and Lupin Ltd, and is included in forty-three NDAs. It is available from forty-nine 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. One supplier is 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. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 076209
| Tradename: | KETOROLAC TROMETHAMINE |
| Applicant: | Amphastar Pharm |
| Ingredient: | ketorolac tromethamine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076209
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076209
Suppliers and Packaging for NDA: 076209
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 076209 | ANDA | Amphastar Pharmaceuticals, Inc. | 0548-9021 | 0548-9021-00 | 10 VIAL in 1 CARTON (0548-9021-00) > 1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
| Approval Date: | Jul 21, 2004 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
| Approval Date: | Jul 21, 2004 | TE: | AP | RLD: | No | ||||
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