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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211533
Company: MSN

Products on ANDA 211533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/211533Orig1s000Panoramaltr.pdf

Therapeutic Equivalents for ANDA 211533

DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE

TABLET;ORAL; 10MG;EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	211533	MSN
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	211537	TORRENT

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