Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208815
Company: ACTAVIS LABS FL INC

Products on ANDA 208815

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELTROMBOPAG	ELTROMBOPAG	50MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208815

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2017	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.