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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076209

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NDA 076209 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz Inc, Sun Pharm, West-ward Pharms Int, Wockhardt, Akorn, Aurobindo Pharma Ltd, Micro Labs Ltd India, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, and Lupin Ltd, and is included in forty-three NDAs. It is available from forty-nine suppliers. Additional details are available on the KETOROLAC TROMETHAMINE profile page.

The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 076209
Tradename:KETOROLAC TROMETHAMINE
Applicant:Amphastar Pharm
Ingredient:ketorolac tromethamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076209
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 076209
Suppliers and Packaging for NDA: 076209
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 076209 ANDA Amphastar Pharmaceuticals, Inc. 0548-9021 0548-9021-00 10 VIAL in 1 CARTON (0548-9021-00) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Jul 21, 2004TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Jul 21, 2004TE:APRLD:No

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