Details for New Drug Application (NDA): 209610

NDA 209610 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 twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for 209610

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

Pharmacology for NDA: 209610

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 209610

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	209610	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-383	45802-383-01	50 g in 1 BOTTLE, PUMP (45802-383-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	3.75%;EQ 1.2% BASE
Approval Date:	Aug 20, 2024	TE:	AB	RLD:	No

Complete Access Available with Subscription