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Last Updated: May 14, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205128

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NDA 205128 describes CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Anda Repository, Glenmark Pharms, Mylan Pharms Inc, Perrigo Israel, Perrigo Uk Finco, Taro, Taro Pharms, Tolmar, and Zydus Pharms, and is included in fourteen NDAs. It is available from ten suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Pharmacology for NDA: 205128
Suppliers and Packaging for NDA: 205128
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 205128 ANDA Actavis Pharma, Inc. 0591-3916 0591-3916-68 1 BOTTLE, PUMP in 1 CARTON (0591-3916-68) > 50 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2.5%;EQ 1.2% BASE
Approval Date:Jun 19, 2015TE:ABRLD:No

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