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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
UBS
Daiichi Sankyo
Covington
US Department of Justice
QuintilesIMS
Boehringer Ingelheim
Queensland Health
Colorcon

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204371

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NDA 204371 describes GRISEOFULVIN, ULTRAMICROSIZE, which is a drug marketed by Mountain and is included in one NDA. It is available from three suppliers. Additional details are available on the GRISEOFULVIN, ULTRAMICROSIZE profile page.

The generic ingredient in GRISEOFULVIN, ULTRAMICROSIZE 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 204371
Tradename:GRISEOFULVIN, ULTRAMICROSIZE
Applicant:Mountain
Ingredient:griseofulvin, ultramicrosize
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204371
Suppliers and Packaging for NDA: 204371
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 204371 ANDA Impax Generics 0115-1724 N 0115-1724-01
GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 204371 ANDA Impax Generics 0115-1724 N 0115-1724-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Jan 9, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 9, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Healthtrust
Harvard Business School
UBS
Colorcon
Fish and Richardson
Citi
Johnson and Johnson
Farmers Insurance

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