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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 050448

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NDA 050448 describes GRIFULVIN V, which is a drug marketed by Johnson And Johnson, Valeant Luxembourg, and J And J, and is included in four NDAs. Additional details are available on the GRIFULVIN V profile page.

The generic ingredient in GRIFULVIN V is griseofulvin, microsize. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, microsize profile page.

Summary for 050448

Tradename:	GRIFULVIN V
Applicant:	Johnson And Johnson
Ingredient:	griseofulvin, microcrystalline
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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