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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203349
Company: GLAND

Products on ANDA 203349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/2020	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/08/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203349

ESOMEPRAZOLE SODIUM

INJECTABLE;INTRAVENOUS; EQ 20MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203349	GLAND

INJECTABLE;INTRAVENOUS; EQ 40MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207181	DEVA HOLDING AS
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	214046	EPIC PHARMA LLC
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203349	GLAND
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215732	SLATE RUN PHARMA

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