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Generated: February 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076583

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NDA 076583 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, Aurobindo Pharma Ltd, Mylan, Pliva, Teva, and Watson Labs, and is included in forty-one NDAs. It is available from fifty-seven 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. Sixty-one suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 076583
Tradename:KETOROLAC TROMETHAMINE
Applicant:Sandoz Inc
Ingredient:ketorolac tromethamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076583
Medical Subject Heading (MeSH) Categories for 076583
Suppliers and Packaging for NDA: 076583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 076583 ANDA Sandoz Inc 61314-126 61314-126-05 5 mL in 1 BOTTLE (61314-126-05)
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 076583 ANDA Sandoz Inc 61314-126 61314-126-10 10 mL in 1 BOTTLE (61314-126-10)

Profile for product number 001

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

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