An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207920
Company: ASTRAZENECA LP

Summary Review

Products on NDA 207920

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207920

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207920Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207920Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207920Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207920Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207920Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207920Orig1s007ltr.pdf
04/04/2019	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207920Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207920Orig1s005ltr.pdf
12/18/2017	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207920Orig1s002.pdf
02/03/2017	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207920orig1s001ltr.pdf

Labels for NDA 207920

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207920Orig1s007lbl.pdf
04/04/2019	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207920Orig1s005lbl.pdf
12/18/2017	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920Orig1s002lbl.pdf
02/03/2017	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920orig1s001lbl.pdf
11/23/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207920Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

NEXIUM 24HR

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	No	211571	DR REDDYS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	No	212088	MYLAN
NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	Yes	207920	ASTRAZENECA LP

Top