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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 074754


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NDA 074754 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Alembic, Amphastar Pharm, Apotex Inc, Apothecon, Aspiro, Baxter Hlthcare Corp, Bedford, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Sagent Pharms Inc, Sandoz, Steriscience, Sun Pharm, Wockhardt, Wockhardt Bio Ag, Chartwell Rx, Epic Pharma Llc, Micro Labs Ltd India, Atnahs Pharma Us, Bionpharma, Hetero Labs Ltd Iii, Leading, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Zydus Lifesciences, and Lupin Ltd, and is included in fifty-six NDAs. It is available from sixty-five 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. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 074754
Tradename:KETOROLAC TROMETHAMINE
Applicant:Teva
Ingredient:ketorolac tromethamine
Patents:0
Pharmacology for NDA: 074754
Mechanism of ActionCyclooxygenase Inhibitors
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 Lake Erie Medical DBA Quality Care Products LLC 35356-696 35356-696-10 10 TABLET, FILM COATED in 1 BOTTLE (35356-696-10)

Profile for product number 001

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

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