Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209900

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NDA 209900 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 209900
Tradename:KETOROLAC TROMETHAMINE
Applicant:Baxter Hlthcare Corp
Ingredient:ketorolac tromethamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209900
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 209900
Suppliers and Packaging for NDA: 209900
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 209900 ANDA Baxter Healthcare Corporation 0338-0069 0338-0069-10 10 VIAL in 1 CARTON (0338-0069-10) > 1 mL in 1 VIAL
KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 209900 ANDA Baxter Healthcare Corporation 0338-0072 0338-0072-25 25 VIAL in 1 CARTON (0338-0072-25) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Sep 15, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Jul 25, 2018TE:APRLD:No

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