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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205379
Company: ACCORD HLTHCARE

Products on ANDA 205379

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2015	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205379Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205379Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/17/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/17/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/17/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/17/2020	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 205379

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205379Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205379

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

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