Is there a generic for Tioconazole?

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

What is the reference-listed drug for Tioconazole?

VAGISTAT-1 (NDA 020676, COMBE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tioconazole are approved?

Tioconazole is approved in the following dosage forms: cream, ointment.

FDA Orange Book · active-ingredient family

Tioconazole

Tioconazole is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VAGISTAT-1 · NDA 020676

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, ointment

Product	Applicant	Application	TE	Approved
VAGISTAT-1RLD	COMBE	NDA 020676	—	Feb 11, 1997
TZ-3	PFIZER	NDA 018682	—	Feb 18, 1983

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
TIOCONAZOLE	PERRIGO	ANDA 075915	—	Nov 21, 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.

Tioconazole — frequently asked questions

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

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