Is there a generic for Oxiconazole nitrate?

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

What is the reference-listed drug for Oxiconazole nitrate?

OXISTAT (NDA 020209, ANI PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Oxiconazole nitrate are approved?

Oxiconazole nitrate is approved in the following dosage forms: cream, lotion.

FDA Orange Book · active-ingredient family

Oxiconazole nitrate

Oxiconazole nitrate 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:OXISTAT · NDA 020209

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, lotion

Product	Applicant	Application	TE	Approved
OXISTATRLD	ANI PHARMS	NDA 020209	—	Sep 30, 1992
OXISTATRLD	FOUGERA PHARMS	NDA 019828	AB	Dec 30, 1988

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
OXICONAZOLE NITRATE	SUN PHARMA CANADA	ANDA 205076	AB	Mar 07, 2016

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.

Oxiconazole nitrate — frequently asked questions

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

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