Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205057
Company: ROXANE

Products on ANDA 205057

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAPENTADOL	TAPENTADOL	50MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
TAPENTADOL	TAPENTADOL	75MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
TAPENTADOL	TAPENTADOL	100MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205057

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2015	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.