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

Summary for NDA: 050756

Valeant Bermuda
benzoyl peroxide; clindamycin phosphate
Formulation / Manufacturing:see details

Pharmacology for NDA: 050756

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
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL 050756 NDA Valeant Pharmaceuticals North America LLC 0187-5190 0187-5190-25 1 JAR in 1 CARTON (0187-5190-25) > 25 g in 1 JAR
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL 050756 NDA Valeant Pharmaceuticals North America LLC 0187-5190 0187-5190-35 1 BOTTLE, PUMP in 1 CARTON (0187-5190-35) > 35 g in 1 BOTTLE, PUMP

Summary for product number 001

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

Summary 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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