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Generated: November 15, 2018

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Details for New Drug Application (NDA): 065438

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NDA 065438 describes GRISEOFULVIN, which is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla Ltd, Vintage Pharms, Sandoz Inc, Sigmapharm Labs Llc, and Mountain, and is included in eight NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
Summary for 065438
Tradename:GRISEOFULVIN
Applicant:Vintage Pharms
Ingredient:griseofulvin, microsize
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Oct 8, 2010TE:ABRLD:No

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