Is there a generic for Danazol?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Danazol, referencing the brand DANOCRINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Danazol?

DANOCRINE (NDA 017557, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Danazol are approved?

Danazol is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Danazol

Danazol is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DANOCRINE · NDA 017557

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
DANOCRINE×3	SANOFI AVENTIS US	NDA 017557	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
DANAZOL×3	LANNETT CO INC	ANDA 077246	AB	Apr 19, 2007
DANAZOL×3	BARR	ANDA 074582	AB	May 29, 1998
DANAZOL	AM THERAP	ANDA 071569	—	Dec 30, 1987

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.

Danazol — frequently asked questions

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

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