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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 206575


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NDA 206575 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 thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 206575
Tradename:CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Applicant:Sun Pharma Canada
Ingredient:benzoyl peroxide; clindamycin phosphate
Patents:0
Pharmacology for NDA: 206575
Physiological EffectDecreased Sebaceous Gland Activity
Neuromuscular Blockade
Suppliers and Packaging for NDA: 206575
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 206575 ANDA Sun Pharmaceutical Industries, Inc. 51672-1367 51672-1367-3 1 BOTTLE, PUMP in 1 CARTON (51672-1367-3) / 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:Aug 19, 2019TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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