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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 050051

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NDA 050051 describes GRISACTIN, which is a drug marketed by Wyeth Ayerst and is included in four NDAs. Additional details are available on the GRISACTIN profile page.

The generic ingredient in GRISACTIN is griseofulvin, ultramicrocrystalline. There is one drug master file entry for this compound. Additional details are available on the griseofulvin, ultramicrocrystalline profile page.

Summary for 050051

Tradename:	GRISACTIN
Applicant:	Wyeth Ayerst
Ingredient:	griseofulvin, microcrystalline
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	125MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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