Details for New Drug Application (NDA): 062645

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NDA 062645 describes ULTRAGRIS-165, which is a drug marketed by Pliva and is included in one NDA. Additional details are available on the ULTRAGRIS-165 profile page.

The generic ingredient in ULTRAGRIS-165 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 062645

Tradename:	ULTRAGRIS-165
Applicant:	Pliva
Ingredient:	griseofulvin, ultramicrocrystalline
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	165MG
Approval Date:	Jun 30, 1992	TE:		RLD:	No

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