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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076722

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NDA 076722 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 076722

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

Pharmacology for NDA: 076722

Medical Subject Heading (MeSH) Categories for 076722

Suppliers and Packaging for NDA: 076722

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 076722 ANDA Gland Pharma Limited 68083-103 68083-103-01 10 SYRINGE in 1 CARTON (68083-103-01) > 1 mL in 1 SYRINGE
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 076722 ANDA Gland Pharma Limited 68083-104 68083-104-01 10 SYRINGE in 1 CARTON (68083-104-01) > 1 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Jul 27, 2004TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Jul 27, 2004TE:RLD:No


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