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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076109

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NDA 076109 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 076109

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076109

Medical Subject Heading (MeSH) Categories for 076109

Suppliers and Packaging for NDA: 076109

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 076109 ANDA Apotex Corp. 60505-1003 60505-1003-1 1 BOTTLE, DROPPER in 1 CARTON (60505-1003-1) > 5 mL in 1 BOTTLE, DROPPER
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 076109 ANDA Apotex Corp. 60505-1003 60505-1003-2 1 BOTTLE, DROPPER in 1 CARTON (60505-1003-2) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

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