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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Argus Health
US Department of Justice
Cantor Fitzgerald

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065354

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NDA 065354 describes GRISEOFULVIN, which is a drug marketed by Perrigo Co Tennessee, Vintage Pharms, Cipla Ltd, Sigmapharm Labs Llc, Sandoz Inc, Actavis Mid Atlantic, and Riconpharma Llc, and is included in eight NDAs. It is available from eight 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. Six suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

Summary for NDA: 065354

Formulation / Manufacturing:see details

Pharmacology for NDA: 065354

Suppliers and Packaging for NDA: 065354

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
griseofulvin, microsize
SUSPENSION;ORAL 065354 ANDA Teva Pharmaceuticals USA, Inc. 0093-7102 0093-7102-12 120 mL in 1 BOTTLE (0093-7102-12)
griseofulvin, microsize
SUSPENSION;ORAL 065354 ANDA Cipla USA Inc. 69097-361 69097-361-08 120 mL in 1 BOTTLE (69097-361-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Sep 10, 2007TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Argus Health
Boehringer Ingelheim
Johnson and Johnson

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