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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Generated: December 18, 2017

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, Alcon Pharms Ltd, Mylan, Pliva, Teva, and Watson Labs, and is included in thirty-nine NDAs. It is available from fifty 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-four suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for 074802

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 0409-3793-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3793-01) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-3793-19)
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 074802 ANDA Hospira, Inc. 0409-3795 0409-3795-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3795-01) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-3795-19)

Summary for product number 001

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

Summary for product number 002

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


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Healthtrust
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