Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208757
Company: ACTAVIS LABS UT INC

Products on ANDA 208757

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZOYL PEROXIDE AND CLINDAMYCIN PHOSPHATE	BENZOYL PEROXIDE;CLINDAMYCIN PHOSPHATE	3.75%; EQ 1.2% BASE	GEL;TOPICAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208757

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2021	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208757Orig1s000TA_ltr.pdf