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Julphar
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203242

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NDA 203242 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 203242
Tradename:KETOROLAC TROMETHAMINE
Applicant:Fresenius Kabi Usa
Ingredient:ketorolac tromethamine
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203242
Medical Subject Heading (MeSH) Categories for 203242
Suppliers and Packaging for NDA: 203242
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 203242 ANDA Fresenius Kabi USA, LLC 76045-104 N 76045-104-10
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 203242 ANDA Fresenius Kabi USA, LLC 76045-105 N 76045-105-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Oct 7, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Oct 7, 2015TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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Johnson and Johnson
McKinsey
Federal Trade Commission
Moodys
Covington
Chubb

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