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Last Updated: April 12, 2025

Details for New Drug Application (NDA): 203242

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NDA 203242 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 Speclts, 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-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 203242

Tradename:	KETOROLAC TROMETHAMINE
Applicant:	Fresenius Kabi Usa
Ingredient:	ketorolac tromethamine
Patents:	0

Pharmacology for NDA: 203242

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 203242

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 203242

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	203242	ANDA	Fresenius Kabi USA, LLC	76045-104	76045-104-10	24 BLISTER PACK in 1 CARTON (76045-104-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	203242	ANDA	Fresenius Kabi USA, LLC	76045-105	76045-105-20	24 BLISTER PACK in 1 CARTON (76045-105-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/ML
Approval Date:	Oct 7, 2015	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML
Approval Date:	Oct 7, 2015	TE:	AP	RLD:	No

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