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Generated: November 15, 2018

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Details for New Drug Application (NDA): 065394

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NDA 065394 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 065394
Tradename:GRISEOFULVIN
Applicant:Actavis Mid Atlantic
Ingredient:griseofulvin, microsize
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065394
Suppliers and Packaging for NDA: 065394
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN griseofulvin, microsize SUSPENSION;ORAL 065394 ANDA Actavis Pharma, Inc. 0472-0013 0472-0013-04 120 mL in 1 BOTTLE (0472-0013-04)
GRISEOFULVIN griseofulvin, microsize SUSPENSION;ORAL 065394 ANDA Rebel Distributors Corp 42254-306 42254-306-04 120 mL in 1 BOTTLE (42254-306-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Jul 6, 2007TE:ABRLD:No

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