Is there a generic for Meclofenamate sodium?

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Meclofenamate sodium, referencing the brand MECLOMEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Meclofenamate sodium?

MECLOMEN (NDA 018006, PARKE DAVIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Meclofenamate sodium are approved?

Meclofenamate sodium is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Meclofenamate sodium

Meclofenamate sodium is approved as 1 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MECLOMEN · NDA 018006

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
MECLOMEN×2	PARKE DAVIS	NDA 018006	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (20)

Product	Applicant	Application	TE	Approved
MECLOFENAMATE SODIUM	BARR	ANDA 072848	—	Mar 20, 1989
MECLOFENAMATE SODIUM	BARR	ANDA 072809	—	Mar 20, 1989
MECLOFENAMATE SODIUM	CHARTWELL RX	ANDA 072262	—	Nov 29, 1988
MECLOFENAMATE SODIUM	CHARTWELL RX	ANDA 072263	—	Nov 29, 1988
MECLOFENAMATE SODIUM	VITARINE	ANDA 071710	—	Jun 15, 1988
MECLOFENAMATE SODIUM	VITARINE	ANDA 071684	—	Jun 15, 1988
MECLOFENAMATE SODIUM	USL PHARMA	ANDA 071007	—	Mar 25, 1988
MECLOFENAMATE SODIUM	USL PHARMA	ANDA 071008	—	Mar 25, 1988
MECLOFENAMATE SODIUM	PAR PHARM	ANDA 072077	—	Mar 10, 1988
MECLOFENAMATE SODIUM	PAR PHARM	ANDA 072078	—	Mar 10, 1988
MECLOFENAMATE SODIUM	WATSON LABS	ANDA 071640	—	Aug 11, 1987
MECLOFENAMATE SODIUM	WATSON LABS	ANDA 071641	—	Aug 11, 1987
MECLODIUM	QUANTUM PHARMICS	ANDA 071380	—	Jul 14, 1987
MECLODIUM	QUANTUM PHARMICS	ANDA 071381	—	Jul 14, 1987
MECLOFENAMATE SODIUM×2	ANI PHARMS	ANDA 071469	—	Apr 15, 1987
MECLOFENAMATE SODIUM	AM THERAP	ANDA 071362	—	Feb 10, 1987
MECLOFENAMATE SODIUM	AM THERAP	ANDA 071363	—	Feb 10, 1987
MECLOFENAMATE SODIUM	WATSON LABS	ANDA 070400	—	Nov 25, 1986
MECLOFENAMATE SODIUM	WATSON LABS	ANDA 070401	—	Nov 25, 1986
MECLOFENAMATE SODIUM×2	MYLAN	ANDA 071081	—	Sep 03, 1986

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Meclofenamate sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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