Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 219408
Company: SCIEGEN PHARMACEUTICALS INC

Products on ANDA 219408

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219408

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/08/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.