Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212339
Company: SUN PHARM INDS INC

Products on ANDA 212339

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMPAGLIFLOZIN; LINAGLIPTIN	EMPAGLIFLOZIN;LINAGLIPTIN	10MG/5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
EMPAGLIFLOZIN; LINAGLIPTIN	EMPAGLIFLOZIN;LINAGLIPTIN	25MG/5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212339

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2023	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.