Details for New Drug Application (NDA): 212433

NDA 212433 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 212433

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

Pharmacology for NDA: 212433

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 212433

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	212433	ANDA	Encube Ethicals, Inc.	21922-022	21922-022-06	1 TUBE in 1 CARTON (21922-022-06) / 45 g in 1 TUBE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	212433	ANDA	Bryant Ranch Prepack	71335-2878	71335-2878-1	1 TUBE in 1 CARTON (71335-2878-1) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%;1.2%
Approval Date:	Apr 28, 2021	TE:	AB	RLD:	No

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