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Last Updated: January 4, 2025

Details for New Drug Application (NDA): 073517

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NDA 073517 describes KETOPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Alkermes Gainesville, Mylan, Misemer, Rising, Teva, and Perrigo, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the KETOPROFEN profile page.

The generic ingredient in KETOPROFEN is ketoprofen. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.

Summary for 073517

Tradename:	KETOPROFEN
Applicant:	Teva
Ingredient:	ketoprofen
Patents:	0

Pharmacology for NDA: 073517

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 073517

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 073517

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOPROFEN	ketoprofen	CAPSULE;ORAL	073517	ANDA	Proficient Rx LP	63187-018	63187-018-30	30 CAPSULE in 1 BOTTLE (63187-018-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Dec 22, 1992	TE:		RLD:	No

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