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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205959
Company: PAR PHARM

Products on ANDA 205959

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAXAGLIPTIN	SAXAGLIPTIN	2.5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
SAXAGLIPTIN	SAXAGLIPTIN	5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205959

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2016	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205959Orig1s000TAltr.pdf

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