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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210794


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NDA 210794 describes CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Pharms, Mylan Pharms Inc, Padagis Israel, Taro, and Zydus Pharms, and is included in fifteen NDAs. It is available from twelve 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.
Summary for 210794
Pharmacology for NDA: 210794
Suppliers and Packaging for NDA: 210794
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 210794 ANDA Zydus Pharmaceuticals USA Inc. 70710-1445 70710-1445-4 1 TUBE in 1 CARTON (70710-1445-4) / 45 g in 1 TUBE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 210794 ANDA Zydus Lifesciences Limited 70771-1450 70771-1450-4 1 TUBE in 1 CARTON (70771-1450-4) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;1.2%
Approval Date:Dec 28, 2018TE:ABRLD:No

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