Details for New Drug Application (NDA): 061996

NDA 061996 describes FULVICIN P/G 330, which is a drug marketed by Chartwell Rx and is included in one NDA. It is available from two suppliers. Additional details are available on the FULVICIN P/G 330 profile page.

The generic ingredient in FULVICIN P/G 330 is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

Summary for 061996

Tradename:	FULVICIN P/G 330
Applicant:	Chartwell Rx
Ingredient:	griseofulvin, ultramicrosize
Patents:	0

Pharmacology for NDA: 061996

Physiological Effect

Decreased Mitosis Microtubule Inhibition

Suppliers and Packaging for NDA: 061996

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996	ANDA	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-863	23155-863-01	100 TABLET in 1 BOTTLE, PLASTIC (23155-863-01)
FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996	ANDA	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-864	23155-864-01	100 TABLET in 1 BOTTLE, PLASTIC (23155-864-01)

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:	No

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:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	165MG
Approval Date:	Apr 6, 1982	TE:		RLD:	No

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