Details for New Drug Application (NDA): 210794

NDA 210794 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 210794

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

Pharmacology for NDA: 210794

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 210794

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	210794	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1445	70710-1445-4	1 TUBE in 1 CARTON (70710-1445-4) / 45 g in 1 TUBE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	210794	ANDA	Zydus Lifesciences Limited	70771-1450	70771-1450-4	1 TUBE in 1 CARTON (70771-1450-4) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%;1.2%
Approval Date:	Dec 28, 2018	TE:	AB	RLD:	No

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