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Serving hundreds of leading biopharmaceutical companies globally:

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Chinese Patent Office
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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077308

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NDA 077308 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 077308
Applicant:Apotex Inc
Ingredient:ketorolac tromethamine
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077308
Medical Subject Heading (MeSH) Categories for 077308
Suppliers and Packaging for NDA: 077308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 077308 ANDA Rebel Distributors Corp 21695-985 E 21695-985-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.4%
Approval Date:Nov 5, 2009TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Farmers Insurance
Fish and Richardson

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