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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074802

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NDA 074802 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 fifty-one 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. Fifty-five suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 074802
Ingredient:ketorolac tromethamine
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074802
Medical Subject Heading (MeSH) Categories for 074802
Suppliers and Packaging for NDA: 074802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 074802 ANDA Hospira, Inc. 0409-3793 N 0409-3793-01
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 074802 ANDA Hospira, Inc. 0409-3795 N 0409-3795-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Jun 5, 1997TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Jun 5, 1997TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Chinese Patent Office
Boehringer Ingelheim
Daiichi Sankyo

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