Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202564
Company: ACTAVIS MID ATLANTIC

Products on ANDA 202564

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE AND TRETINOIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202564

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202564Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 202564

CLINDAMYCIN PHOSPHATE AND TRETINOIN

GEL;TOPICAL; 1.2%;0.025%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE AND TRETINOIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	No	AB1	202564	ACTAVIS MID ATLANTIC
ZIANA	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	Yes	AB1	050802	BAUSCH