Last Updated: November 8, 2026

Details for New Drug Application (NDA): 065200

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NDA 065200 describes GRISEOFULVIN, which is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla, Cosette Pharms Nc, 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 are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

Summary for 065200

Tradename:	GRISEOFULVIN
Applicant:	Chartwell Rx
Ingredient:	griseofulvin, microsize
Patents:	0

Pharmacology for NDA: 065200

Physiological Effect	Decreased Mitosis Microtubule Inhibition

Suppliers and Packaging for NDA: 065200

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065200	ANDA	Chartwell RX, LLC.	62135-968	62135-968-41	120 mL in 1 BOTTLE (62135-968-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Mar 2, 2005	TE:	AB	RLD:	No

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