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UBS
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QuintilesIMS
Colorcon
Harvard Business School
Healthtrust
US Army
Fuji

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050756

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NDA 050756 describes BENZACLIN, which is a drug marketed by Valeant Bermuda and is included in one NDA. It is available from three suppliers. Additional details are available on the BENZACLIN profile page.

The generic ingredient in BENZACLIN 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 050756
Tradename:BENZACLIN
Applicant:Valeant Bermuda
Ingredient:benzoyl peroxide; clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050756
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050756
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756 NDA Valeant Pharmaceuticals North America LLC 0187-5190 N 0187-5190-25
BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756 NDA Valeant Pharmaceuticals North America LLC 0187-5190 N 0187-5190-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;EQ 1% BASE
Approval Date:Dec 21, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TOPICALStrength5%;EQ 1% BASE
Approval Date:Apr 20, 2007TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
Cerilliant
Farmers Insurance
Merck
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Harvard Business School
Dow
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