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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065354

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NDA 065354 describes GRISEOFULVIN, which is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla Ltd, Vintage Pharms, Sandoz Inc, Sigmapharm Labs Llc, 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 065354

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065354

Suppliers and Packaging for NDA: 065354

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN griseofulvin, microsize SUSPENSION;ORAL 065354 ANDA Cipla USA Inc. 69097-361 69097-361-08 120 mL in 1 BOTTLE (69097-361-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Sep 10, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Accenture
Fish and Richardson
Argus Health
Citi
Teva
Daiichi Sankyo
Johnson and Johnson
Cipla
AstraZeneca

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