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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 075784

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NDA 075784 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-six 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. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.

Summary for 075784

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

Pharmacology for NDA: 075784

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 075784

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 075784

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075784	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1594	51662-1594-3	25 POUCH in 1 CASE (51662-1594-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1594-2) / 1 mL in 1 VIAL, SINGLE-USE
KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075784	ANDA	Cardinal Health 107, LLC	55154-9366	55154-9366-5	5 VIAL, SINGLE-USE in 1 BAG (55154-9366-5) / 1 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/ML
Approval Date:	Jan 11, 2002	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML
Approval Date:	Jan 11, 2002	TE:	AP	RLD:	No

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