Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204844
Company: SANDOZ INC

Products on ANDA 204844

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204844

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2015	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.