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Generated: May 27, 2017

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Details for New Drug Application (NDA): 203688

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NDA 203688 describes CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Perrigo Israel, Mylan Pharms Inc, and Tolmar, and is included in five NDAs. It is available from four 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. Ten suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for NDA: 203688

Formulation / Manufacturing:see details

Pharmacology for NDA: 203688

Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 203688

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL 203688 ANDA Sandoz Inc. 0781-7161 0781-7161-19 1 TUBE in 1 CARTON (0781-7161-19) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;1.2%
Approval Date:Aug 25, 2016TE:ABRLD:No

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