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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Queensland Health
Harvard Business School

Generated: January 17, 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 Impax Labs Inc and is included in one NDA. It is available from two 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. Six suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
Summary for 204371
Applicant:Impax Labs Inc
Ingredient:griseofulvin, ultramicrosize
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 RiconPharma LLC. 51125-005 51125-005-08 500 TABLET, COATED in 1 BOTTLE, PLASTIC (51125-005-08)
GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 204371 ANDA RiconPharma LLC. 51125-005 51125-005-06 100 TABLET, COATED in 1 BOTTLE, PLASTIC (51125-005-06)

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 leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Farmers Insurance
Cantor Fitzgerald
Chinese Patent Office

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