Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209086
Company: ACTAVIS LABS

Products on ANDA 209086

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INGENOL MEBUTATE	INGENOL MEBUTATE	0.05%	GEL; TOPICAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209086

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2018	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209086Orig1s000TAltr.pdf