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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 074790

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NDA 074790 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-two 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 074790
Tradename:KETOROLAC TROMETHAMINE
Applicant:Cycle Pharms Ltd
Ingredient:ketorolac tromethamine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074790

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Jun 26, 1997TE:RLD:No

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