Is there a generic for Griseofulvin, ultramicrosize?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Griseofulvin, ultramicrosize, referencing the brand GRIS-PEG. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Griseofulvin, ultramicrosize?

GRIS-PEG (NDA 050475, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Griseofulvin, ultramicrosize are approved?

Griseofulvin, ultramicrosize is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Griseofulvin, ultramicrosize

Griseofulvin, ultramicrosize is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GRIS-PEG · NDA 050475

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
GRIS-PEGRLD×2	BAUSCH	NDA 050475	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
GRISEOFULVIN, ULTRAMICROSIZE×2	SANDOZ	ANDA 202805	AB	Dec 26, 2018
GRISEOFULVIN, ULTRAMICROSIZE×2	MOUNTAIN	ANDA 204371	AB	Jan 09, 2014
GRISEOFULVIN,ULTRAMICROSIZE×2	SIGMAPHARM LABS LLC	ANDA 202545	AB	Oct 22, 2012
FULVICIN P/G×4	CHARTWELL RX	ANDA 061996	AB	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.

Griseofulvin, ultramicrosize — frequently asked questions

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

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