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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Farmers Insurance
Harvard Business School
Queensland Health

Generated: December 16, 2017

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. Ten suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for 050741

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 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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 050741

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
StiefelDUACbenzoyl peroxide; clindamycin phosphateGEL;TOPICAL050741-001Aug 26, 2002► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim

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