Is there a generic for Butoconazole nitrate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Butoconazole nitrate, referencing the brand FEMSTAT 3. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Butoconazole nitrate?

FEMSTAT 3 (NDA 020421, BAYER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Butoconazole nitrate are approved?

Butoconazole nitrate is approved in the following dosage forms: cream, suppository.

FDA Orange Book · active-ingredient family

Butoconazole nitrate

Butoconazole nitrate is approved as 4 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FEMSTAT 3 · NDA 020421

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, suppository

Product	Applicant	Application	TE	Approved
FEMSTAT 3RLD	BAYER	NDA 020421	—	Dec 21, 1995
BUTOCONAZOLE NITRATE	PADAGIS US	NDA 019881	—	Feb 07, 1997
FEMSTAT	ROCHE PALO	NDA 019215	—	Nov 25, 1985
FEMSTAT	ROCHE PALO	NDA 019359	—	Nov 25, 1985

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
GYNAZOLE-1	PADAGIS ISRAEL	ANDA 200923	—	May 18, 2012

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.

Butoconazole nitrate — frequently asked questions

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

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