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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 074014

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NDA 074014 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 074014

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

Pharmacology for NDA: 074014

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 074014

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 074014

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOPROFEN	ketoprofen	CAPSULE;ORAL	074014	ANDA	Misemer Pharmaceuticals, Inc.	0276-0504	0276-0504-10	100 CAPSULE in 1 BOTTLE (0276-0504-10)
KETOPROFEN	ketoprofen	CAPSULE;ORAL	074014	ANDA	Misemer Pharmaceuticals, Inc.	0276-0506	0276-0506-10	100 CAPSULE in 1 BOTTLE (0276-0506-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jan 29, 1993	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jan 29, 1993	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Jan 29, 1993	TE:		RLD:	No

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