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Serving leading biopharmaceutical companies globally:

Baxter
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US Department of Justice
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078721

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NDA 078721 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 078721
Tradename:KETOROLAC TROMETHAMINE
Applicant:Alcon Pharms Ltd
Ingredient:ketorolac tromethamine
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078721
Medical Subject Heading (MeSH) Categories for 078721
Suppliers and Packaging for NDA: 078721
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 078721 ANDA Sandoz Inc 61314-018 61314-018-05 5 mL in 1 BOTTLE (61314-018-05)

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 leading biopharmaceutical companies globally:

Johnson and Johnson
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Deloitte
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Moodys

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