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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219213
Company: AUROBINDO PHARMA LTD

Products on ANDA 219213

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219213

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219213

ESOMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 10MG BASE/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	219213	AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	211752	CIPLA
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	212652	TORRENT
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022101	ASTRAZENECA

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