Is there a generic for Sulconazole nitrate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Sulconazole nitrate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Sulconazole nitrate?

EXELDERM (NDA 018737, JOURNEY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sulconazole nitrate are approved?

Sulconazole nitrate is approved in the following dosage forms: cream, solution.

FDA Orange Book · active-ingredient family

Sulconazole nitrate

Sulconazole nitrate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:EXELDERM · NDA 018737

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, solution

Product	Applicant	Application	TE	Approved
EXELDERMRLD	JOURNEY	NDA 018737	—	Feb 28, 1989
EXELDERMRLD	JOURNEY	NDA 018738	—	Aug 30, 1985

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.

Sulconazole nitrate — frequently asked questions

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

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