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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050756

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NDA 050756 describes BENZACLIN, which is a drug marketed by Bausch 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. Sixteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 050756
Ingredient:benzoyl peroxide; clindamycin phosphate
Pharmacology for NDA: 050756
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 Bausch Health US LLC 0187-5190 0187-5190-25 1 JAR in 1 CARTON (0187-5190-25) > 25 g in 1 JAR
BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756 NDA Bausch Health US LLC 0187-5190 0187-5190-35 1 BOTTLE, PUMP in 1 CARTON (0187-5190-35) > 35 g in 1 BOTTLE, PUMP

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 leading biopharmaceutical companies globally:

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