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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 078299

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NDA 078299 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Alembic, Amphastar Pharm, Apotex, 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, 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 078299

Tradename:	KETOROLAC TROMETHAMINE
Applicant:	Onesource Specialty
Ingredient:	ketorolac tromethamine
Patents:	0

Pharmacology for NDA: 078299

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 078299

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 078299

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	078299	ANDA	Onesource Specialty Pharma Limited	83270-153	83270-153-03	25 VIAL, SINGLE-DOSE in 1 CARTON (83270-153-03) / 1 mL in 1 VIAL, SINGLE-DOSE
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	078299	ANDA	Onesource Specialty Pharma Limited	83270-154	83270-154-03	25 VIAL, SINGLE-DOSE in 1 CARTON (83270-154-03) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	15MG/ML
Approval Date:	Jul 16, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML
Approval Date:	Jul 16, 2007	TE:		RLD:	No

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