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Last Updated: December 16, 2019

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. Sixteen 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
Pharmacology for NDA: 050741
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 0145-2371-05 1 TUBE in 1 CARTON (0145-2371-05) > 45 g in 1 TUBE
DUAC benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050741 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-949 66993-949-45 1 TUBE in 1 CARTON (66993-949-45) > 45 g in 1 TUBE
Paragraph IV (Patent) Challenges for 050741
Tradename Dosage Ingredient NDA Submissiondate
DUAC GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050741 2008-12-11

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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