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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075679

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NDA 075679 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 two 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. Two suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.

Summary for 075679

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

Pharmacology for NDA: 075679

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 075679

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 075679

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOPROFEN	ketoprofen	CAPSULE, EXTENDED RELEASE;ORAL	075679	ANDA	Mylan Pharmaceuticals Inc.	0378-8200	0378-8200-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Feb 20, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Feb 20, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Feb 20, 2002	TE:		RLD:	No

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