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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 209610


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NDA 209610 describes CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Speclt, Mylan Pharms Inc, Padagis Israel, Sun Pharma Canada, and Zydus Pharms, and is included in sixteen NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 209610
Tradename:CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Applicant:Padagis Israel
Ingredient:benzoyl peroxide; clindamycin phosphate
Patents:0
Pharmacology for NDA: 209610
Physiological EffectDecreased Sebaceous Gland Activity
Neuromuscular Blockade
Suppliers and Packaging for NDA: 209610
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 209610 ANDA Padagis Israel Pharmaceuticals Ltd 45802-383 45802-383-01 50 g in 1 BOTTLE, PUMP (45802-383-01)
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 209610 ANDA Mayne Pharma 68308-127 68308-127-50 50 g in 1 BOTTLE, PUMP (68308-127-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength3.75%;EQ 1.2% BASE
Approval Date:Aug 20, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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