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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215745

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NDA 215745 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, Onesource Specialty, Sagent Pharms Inc, Sandoz, Sun Pharm, Wockhardt Bio Ag, Apotex, 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 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 215745

Tradename:	KETOROLAC TROMETHAMINE
Applicant:	Leading
Ingredient:	ketorolac tromethamine
Patents:	0

Pharmacology for NDA: 215745

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 215745

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 215745

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOROLAC TROMETHAMINE	ketorolac tromethamine	TABLET;ORAL	215745	ANDA	Leading Pharma, LLC	69315-260	69315-260-01	100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01)
KETOROLAC TROMETHAMINE	ketorolac tromethamine	TABLET;ORAL	215745	ANDA	PD-Rx Pharmaceuticals, Inc.	72789-437	72789-437-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 23, 2023	TE:	AB	RLD:	No

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