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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Queensland Health
Harvard Business School
Boehringer Ingelheim

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050475

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NDA 050475 describes GRIS-PEG, which is a drug marketed by Valeant Pharms Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the GRIS-PEG profile page.

The generic ingredient in GRIS-PEG 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 050475
Applicant:Valeant Pharms Inc
Ingredient:griseofulvin, ultramicrosize
Formulation / Manufacturing:see details
Pharmacology for NDA: 050475
Suppliers and Packaging for NDA: 050475
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRIS-PEG griseofulvin, ultramicrosize TABLET;ORAL 050475 NDA Pedinol Pharmacal, Inc. 0884-0763 N 0884-0763-04
GRIS-PEG griseofulvin, ultramicrosize TABLET;ORAL 050475 NDA Pedinol Pharmacal, Inc. 0884-0773 N 0884-0773-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Boehringer Ingelheim
Cantor Fitzgerald

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