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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205190

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NDA 205190 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-five 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 205190

Tradename:	KETOROLAC TROMETHAMINE
Applicant:	Eugia Pharma
Ingredient:	ketorolac tromethamine
Patents:	0

Pharmacology for NDA: 205190

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 205190

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 205190

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOROLAC TROMETHAMINE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	205190	ANDA	Aurobindo Pharma Limited	65862-770	65862-770-05	1 BOTTLE in 1 CARTON (65862-770-05) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Dec 3, 2020	TE:		RLD:	No

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