Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 217055
Company: AJANTA PHARMA LTD

Products on ANDA 217055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMPAGLIFLOZIN	EMPAGLIFLOZIN	25MG	TABLET	None (Tentative Approval)	None	No	No
EMPAGLIFLOZIN	EMPAGLIFLOZIN	10MG	TABLET	None (Tentative Approval)	None	No	No
EMPAGLIFLOZIN	EMPAGLIFLOZIN	2.5MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.