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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211751
Company: CIPLA

Products on ANDA 211751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	AB	No	No
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211751Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/11/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/11/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/11/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/11/2023	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211751

ESOMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 20MG 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 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	211751	CIPLA
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	206055	ZYDUS PHARMS
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021957	ASTRAZENECA

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 40MG 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 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	211751	CIPLA
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	206055	ZYDUS PHARMS
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021957	ASTRAZENECA

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