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: 4 brands, 1 generic; first approved Nov 25, 1985; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

FEMSTAT 3RLD
BAYERNDA 0204211995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM VAGINAL Discontinued —
BUTOCONAZOLE NITRATE
PADAGIS USNDA 0198811997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM VAGINAL Discontinued —
FEMSTAT
ROCHE PALONDA 0192151985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM VAGINAL Discontinued —
FEMSTAT
ROCHE PALONDA 0193591985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG SUPPOSITORY VAGINAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	SUPPOSITORY	VAGINAL	Discontinued	—

Generic (ANDA) products (1)

Abbreviated applications

GYNAZOLE-1RS
PADAGIS ISRAELANDA 2009232012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM VAGINAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	VAGINAL	Rx	—

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

First approval

Nov 25, 1985

41 yr 4 mo ago

Most recent approval

May 18, 2012

14 yr 6 mo ago

Approvals span 1985–2012 across 5 FDA applications.

Brand (NDA) 480%

Generic (ANDA) 120%

Butoconazole nitrate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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