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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202482

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NDA 202482 describes GRISEOFULVIN, which is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla, Cosette, Sandoz, Sigmapharm Labs Llc, and Mountain, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the GRISEOFULVIN profile page.

The generic ingredient in GRISEOFULVIN 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 202482

Tradename:	GRISEOFULVIN
Applicant:	Sigmapharm Labs Llc
Ingredient:	griseofulvin, microsize
Patents:	0

Pharmacology for NDA: 202482

Physiological Effect	Decreased Mitosis Microtubule Inhibition

Suppliers and Packaging for NDA: 202482

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GRISEOFULVIN	griseofulvin, microsize	TABLET;ORAL	202482	ANDA	Sigmapharm Laboratories, LLC	42794-012	42794-012-08	30 TABLET in 1 BOTTLE (42794-012-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Oct 22, 2012	TE:	AB	RLD:	No

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