Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206218
Company: SUN PHARMA CANADA

Products on ANDA 206218

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206218

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206218

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

GEL;TOPICAL; 5%;1.2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	212433	ENCUBE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	090979	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	206218	SUN PHARMA CANADA
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	210794	ZYDUS PHARMS
DUAC	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	Yes	AB	050741	STIEFEL