Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214054
Company: INTAS PHARMS USA

Products on ANDA 214054

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SITAGLIPTIN	SITAGLIPTIN	25MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
SITAGLIPTIN	SITAGLIPTIN	50MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
SITAGLIPTIN	SITAGLIPTIN	100MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214054

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/02/2022	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.