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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091592

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NDA 091592 describes GRISEOFULVIN, which is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla Ltd, Vintage Pharms, Sandoz Inc, Sigmapharm Labs Llc, and Mountain, and is included in eight NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.
Summary for 091592
Tradename:GRISEOFULVIN
Applicant:Sandoz Inc
Ingredient:griseofulvin, microsize
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091592
Suppliers and Packaging for NDA: 091592
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN griseofulvin, microsize TABLET;ORAL 091592 ANDA Sandoz Inc 0781-5514 0781-5514-01 100 TABLET in 1 BOTTLE (0781-5514-01)
GRISEOFULVIN griseofulvin, microsize TABLET;ORAL 091592 ANDA Sandoz Inc 0781-5514 0781-5514-05 500 TABLET in 1 BOTTLE (0781-5514-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 7, 2013TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 7, 2013TE:ABRLD:No

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