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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217789

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NDA 217789 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 217789

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

Pharmacology for NDA: 217789

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 217789

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 217789

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	217789	ANDA	Caplin Steriles Limited	65145-145	65145-145-25	25 VIAL, SINGLE-DOSE in 1 CARTON (65145-145-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-145-01)
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	217789	ANDA	Caplin Steriles Limited	65145-146	65145-146-25	25 VIAL, SINGLE-DOSE in 1 CARTON (65145-146-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-146-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/ML
Approval Date:	May 10, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML
Approval Date:	May 10, 2023	TE:	AP	RLD:	No

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