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Daiichi Sankyo
US Department of Justice
Chinese Patent Office

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050557

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NDA 050557 describes BENZAMYCIN, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from four suppliers. Additional details are available on the BENZAMYCIN profile page.

The generic ingredient in BENZAMYCIN is benzoyl peroxide; erythromycin. There are seventeen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.
Summary for 050557
Applicant:Valeant Intl
Ingredient:benzoyl peroxide; erythromycin
Formulation / Manufacturing:see details
Pharmacology for NDA: 050557
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZAMYCIN benzoyl peroxide; erythromycin GEL;TOPICAL 050557 NDA Valeant Pharmaceuticals North America LLC 0187-5205 N 0187-5205-46
BENZAMYCIN benzoyl peroxide; erythromycin GEL;TOPICAL 050557 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-083 E 45802-083-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;3%
Approval Date:Oct 26, 1984TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Daiichi Sankyo

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