Is there a generic for Clioquinol; nystatin?

The FDA Orange Book does not currently list an approved generic (ANDA) for Clioquinol; nystatin. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Clioquinol; nystatin?

NYSTAFORM (NDA 050235, BAYER PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Clioquinol; nystatin are approved?

Clioquinol; nystatin is approved in the following dosage form: ointment.

FDA Orange Book · active-ingredient family

Clioquinol; nystatin

Clioquinol; nystatin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NYSTAFORM · NDA 050235

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · ointment

Product	Applicant	Application	TE	Approved
NYSTAFORM	BAYER PHARMS	NDA 050235	—	Approved Prior to Jan 1, 1982

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.

Clioquinol; nystatin — frequently asked questions

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

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