DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076209
NDA 076209 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Cycle Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Sun Pharma Global, West-ward Pharms Int, Wockhardt, Akorn, Mylan, Pliva, Teva, and Watson Labs, and is included in thirty-nine NDAs. It is available from forty-two suppliers. Additional details are available on the KETOROLAC TROMETHAMINE profile page.
The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 076209
| Tradename: | KETOROLAC TROMETHAMINE |
| Applicant: | Amphastar Pharm |
| Ingredient: | ketorolac tromethamine |
| Patents: | 0 |
| Therapeutic Class: | Analgesics Anti-inflammatory Agents Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076209
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| 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 | N | 0548-9021-00 |
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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