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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050475

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NDA 050475 describes GRIS-PEG, which is a drug marketed by Bausch and is included in one NDA. Additional details are available on the GRIS-PEG profile page.

The generic ingredient in GRIS-PEG is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

Summary for 050475

Tradename:	GRIS-PEG
Applicant:	Bausch
Ingredient:	griseofulvin, ultramicrosize
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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