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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217714
Company: CIPLA

Products on ANDA 217714

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	AB	No	No
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217714Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217714

ESOMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 2.5MG 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 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	217714	CIPLA
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	212651	TORRENT
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021957	ASTRAZENECA

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 5MG 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 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	218948	AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	217714	CIPLA
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	212651	TORRENT
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021957	ASTRAZENECA

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