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Serving leading biopharmaceutical companies globally:

Queensland Health
Fuji
Chubb
Moodys
Johnson and Johnson
Harvard Business School
Daiichi Sankyo
Healthtrust
QuintilesIMS
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075784

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NDA 075784 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 075784

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075784

Medical Subject Heading (MeSH) Categories for 075784

Suppliers and Packaging for NDA: 075784

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075784 ANDA Cardinal Health 55154-9366 55154-9366-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9366-5) > 1 mL in 1 VIAL, SINGLE-DOSE
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075784 ANDA Cardinal Health 55154-9368 55154-9368-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9368-5) > 1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Jan 11, 2002TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Jan 11, 2002TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Baxter
McKinsey
US Army
Colorcon
Healthtrust
Mallinckrodt
Novartis
Farmers Insurance
US Department of Justice

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