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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
US Army
Teva
Harvard Business School
Merck
Queensland Health
Fuji
QuintilesIMS
Boehringer Ingelheim

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203376

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NDA 203376 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 203376
Tradename:KETOROLAC TROMETHAMINE
Applicant:Akorn
Ingredient:ketorolac tromethamine
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203376
Medical Subject Heading (MeSH) Categories for 203376
Suppliers and Packaging for NDA: 203376
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 203376 ANDA Akorn 17478-207 E 17478-207-14

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.45%
Approval Date:Feb 10, 2014TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
AstraZeneca
Argus Health
Merck
Cipla
Boehringer Ingelheim
Express Scripts
Medtronic

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