Details for New Drug Application (NDA): 090979

NDA 090979 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 090979

Tradename:	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Applicant:	Padagis Israel
Ingredient:	benzoyl peroxide; clindamycin phosphate
Patents:	0

Pharmacology for NDA: 090979

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

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	Padagis Israel Pharmaceuticals Ltd	45802-736	45802-736-84	1 TUBE in 1 CARTON (45802-736-84) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%;1.2%
Approval Date:	Jun 26, 2012	TE:	AB	RLD:	No

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