Is there a generic for Flutamide?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Flutamide, referencing the brand EULEXIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Flutamide?

EULEXIN (NDA 018554, SCHERING) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Flutamide are approved?

Flutamide is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Flutamide

Flutamide is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:EULEXIN · NDA 018554

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
EULEXINRLD	SCHERING	NDA 018554	—	Jan 27, 1989

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
FLUTAMIDE	PHARMOBEDIENT	ANDA 076224	—	May 09, 2003
FLUTAMIDE	CIPLA	ANDA 075780	—	Sep 19, 2001
FLUTAMIDE	ACTAVIS LABS FL INC	ANDA 075820	—	Sep 18, 2001
FLUTAMIDE	CHARTWELL RX	ANDA 075818	—	Sep 18, 2001
FLUTAMIDE	WAYLIS THERAP	ANDA 075298	—	Sep 18, 2001

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.

Flutamide — frequently asked questions

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

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