Is there a generic for Griseofulvin, microcrystalline?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Griseofulvin, microcrystalline, referencing the brand GRIFULVIN V. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

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

GRIFULVIN V (NDA 050448, JOHNSON AND JOHNSON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Griseofulvin, microcrystalline are approved?

Griseofulvin, microcrystalline is approved in the following dosage forms: capsule, suspension, tablet.

FDA Orange Book · active-ingredient family

Griseofulvin, microcrystalline

Griseofulvin, microcrystalline is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GRIFULVIN V · NDA 050448

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, suspension, tablet

Product	Applicant	Application	TE	Approved
GRIFULVIN VRLD	JOHNSON AND JOHNSON	NDA 050448	—	Approved Prior to Jan 1, 1982
GRISACTIN×2	WYETH AYERST	NDA 050051	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
GRIFULVIN V×3	J AND J	ANDA 060618	—	Approved Prior to Jan 1, 1982
GRIFULVIN V×2	VALEANT LUXEMBOURG	ANDA 062279	—	Approved Prior to Jan 1, 1982
GRISACTIN	WYETH AYERST	ANDA 060212	—	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, microcrystalline — frequently asked questions

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

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