Details for New Drug Application (NDA): 065443

NDA 065443 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, Taro, 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 065443

Tradename:	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Applicant:	Mylan Pharms Inc
Ingredient:	benzoyl peroxide; clindamycin phosphate
Patents:	0

Suppliers and Packaging for NDA: 065443

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	065443	ANDA	Mylan Pharmaceuticals Inc.	0378-8688	0378-8688-54	1 KIT in 1 CARTON (0378-8688-54) * 10 g in 1 BOTTLE, PLASTIC * 40 g in 1 JAR
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	065443	ANDA	Mylan Pharmaceuticals Inc.	0378-8688	0378-8688-35	1 KIT in 1 CARTON (0378-8688-35) * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%;EQ 1% BASE
Approval Date:	Aug 11, 2009	TE:	AB	RLD:	No

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