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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
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UBS
Moodys
US Army
Dow
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Generated: June 18, 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. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
Summary for 050475
Tradename:GRIS-PEG
Applicant:Valeant Pharms Inc
Ingredient:griseofulvin, ultramicrosize
Patents:0
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:

Teva
McKinsey
Chubb
Argus Health
Express Scripts
Merck
Moodys
Daiichi Sankyo
Mallinckrodt

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