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Details for New Drug Application (NDA): 090979

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NDA 090979 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. Nine suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for NDA: 090979

Tradename:
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Applicant:
Perrigo Israel
Ingredient:
benzoyl peroxide; clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090979

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 090979

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 090979 ANDA Medimetriks Pharmaceuticals 43538-176 43538-176-45 1 TUBE in 1 CARTON (43538-176-45) > 45 g in 1 TUBE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL 090979 ANDA Medimetriks Pharmaceuticals 43538-177 43538-177-45 1 KIT in 1 CARTON (43538-177-45) * 45 g in 1 TUBE (43538-176-45) * 85 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;1.2%
Approval Date:Jun 26, 2012TE:ABRLD:No


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