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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074761

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NDA 074761 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 074761
Tradename:KETOROLAC TROMETHAMINE
Applicant:Mylan
Ingredient:ketorolac tromethamine
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074761
Medical Subject Heading (MeSH) Categories for 074761
Suppliers and Packaging for NDA: 074761
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 074761 ANDA Mylan Pharmaceuticals Inc. 0378-1134 N 0378-1134-01
KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 074761 ANDA PD-Rx Pharmaceuticals, Inc. 43063-174 N 43063-174-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 16, 1997TE:ABRLD:No

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