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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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Chinese Patent Office
QuintilesIMS
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078145

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NDA 078145 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.
Summary for 078145
Tradename:KETOROLAC TROMETHAMINE
Applicant:Luitpold
Ingredient:ketorolac tromethamine
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078145
Medical Subject Heading (MeSH) Categories for 078145
Suppliers and Packaging for NDA: 078145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 078145 ANDA American Regent, Inc. 0517-0601 N 0517-0601-25
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 078145 ANDA American Regent, Inc. 0517-0601 N 0517-0601-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Jan 14, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Jan 14, 2008TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Argus Health
Chubb
Johnson and Johnson
McKesson
Citi
Farmers Insurance
Teva
Fuji

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