Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207194
Company: ENCUBE

Products on ANDA 207194

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207194

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207194Orig1s000TALtr.pdf

Therapeutic Equivalents for ANDA 207194

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

GEL;TOPICAL; 2.5%;EQ 1.2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACANYA	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	Yes	AB	050819	BAUSCH
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	205128	ACTAVIS LABS UT INC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	207194	ENCUBE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	205397	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	206575	SUN PHARMA CANADA