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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
US Army
Boehringer Ingelheim
Fish and Richardson

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050741

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NDA 050741 describes DUAC, which is a drug marketed by Stiefel and is included in one NDA. It is available from two suppliers. Additional details are available on the DUAC profile page.

The generic ingredient in DUAC is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 050741
Ingredient:benzoyl peroxide; clindamycin phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 050741
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050741
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUAC benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050741 NDA Stiefel Laboratories Inc 0145-2371 N 0145-2371-05
DUAC benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050741 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-949 N 66993-949-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;1.2%
Approval Date:Aug 26, 2002TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Queensland Health
Cantor Fitzgerald

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