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Generated: November 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074754

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NDA 074754 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Cycle Pharms Ltd, Apotex Inc, Hospira, Amphastar Pharm, Gland Pharma Ltd, Sun Pharma Global, Alcon Pharms Ltd, West-ward Pharms Int, Bedford, Baxter Hlthcare Corp, Akorn, Fresenius Kabi Usa, Wockhardt, Luitpold, Apothecon, Teva, Mylan Labs Ltd, Watson Labs, Mylan, Sagent Pharms, Sandoz Inc, and Pliva, 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 074754

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

Pharmacology for NDA: 074754

Medical Subject Heading (MeSH) Categories for 074754

Suppliers and Packaging for NDA: 074754

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE
ketorolac tromethamine
TABLET;ORAL 074754 ANDA Teva Pharmaceuticals USA, Inc. 0093-0314 0093-0314-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0314-01)
KETOROLAC TROMETHAMINE
ketorolac tromethamine
TABLET;ORAL 074754 ANDA Blenheim Pharmacal, Inc. 10544-222 10544-222-10 10 TABLET, FILM COATED in 1 BOTTLE (10544-222-10)

Summary for product number 001

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


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