Last Updated: November 8, 2026

Details for New Drug Application (NDA): 221041

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NDA 221041 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Adaptis, 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, Shandong, Sun Pharm, Wockhardt Bio Ag, Chartwell Rx, Epic Pharma Llc, Micro Labs Ltd India, Atnahs Pharma Us, Bionpharma, Hetero Labs Ltd Iii, Leading, Mylan, Pharmazone, Pliva, Teva, Watson Labs, Zydus Lifesciences, and Lupin, and is included in fifty-eight 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 two 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 221041

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

Pharmacology for NDA: 221041

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 221041

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 221041

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	221041	ANDA	Anthea Pharma Private Limited	83854-021	83854-021-10	10 VIAL in 1 CARTON (83854-021-10) / 1 mL in 1 VIAL (83854-021-01)
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	221041	ANDA	Anthea Pharma Private Limited	83854-021	83854-021-25	25 VIAL in 1 CARTON (83854-021-25) / 1 mL in 1 VIAL (83854-021-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/ML
Approval Date:	Sep 25, 2026	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML
Approval Date:	Sep 25, 2026	TE:	AP	RLD:	No

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