DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 074993
NDA 074993 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 074993
| Tradename: | KETOROLAC TROMETHAMINE |
| Applicant: | Hospira |
| Ingredient: | ketorolac tromethamine |
| Patents: | 0 |
| Therapeutic Class: | Analgesics Anti-inflammatory Agents Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074993
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074993
Suppliers and Packaging for NDA: 074993
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 074993 | ANDA | Hospira, Inc. | 0409-2287 | N | 0409-2287-31 |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 074993 | ANDA | Hospira, Inc. | 0409-2287 | N | 0409-2287-61 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
| Approval Date: | Jan 27, 1999 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
| Approval Date: | Jan 27, 1999 | TE: | AP | RLD: | No | ||||
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