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Serving leading biopharmaceutical companies globally:

Fuji
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US Department of Justice
Fish and Richardson
McKinsey
Julphar
Cerilliant
Mallinckrodt
Dow
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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065394

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NDA 065394 describes GRISEOFULVIN, which is a drug marketed by Chartwell Rx, Vintage Pharms, Cipla Ltd, Sigmapharm Labs Llc, Sandoz Inc, Actavis Mid Atlantic, and Impax Labs Inc, and is included in eight 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. Six suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

Summary for NDA: 065394

Tradename:
1
Applicant:
1
Ingredient:
1
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)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

US Department of Justice
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