Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204657
Company: EUGIA PHARMA

Products on ANDA 204657

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2016	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
02/23/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/23/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
02/23/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/23/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/23/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/23/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/23/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204657

ESOMEPRAZOLE SODIUM

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	205379	ACCORD HLTHCARE
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	204657	EUGIA PHARMA
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203349	GLAND PHARMA LTD
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215732	HAINAN POLY
ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	200882	SUN PHARM
NEXIUM IV	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021689	ASTRAZENECA