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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204655
Company: ASTRAZENECA LP

Summary Review

Products on NDA 204655

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204655

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2014	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204655Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204655Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2022	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204655Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204655Orig1s018ltr.pdf
12/04/2020	SUPPL-14	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204655Orig1s014ltr.pdf
04/04/2019	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204655Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204655Orig1s011ltr.pdf
01/24/2018	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204655Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204655Orig1s009ltr.pdf
02/03/2017	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204655Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204655Orig1s007ltr.pdf
01/09/2017	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204655Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204655Orig1s006ltr.pdf
06/17/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/23/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/02/2015	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204655Orig1s002lbl.pdf
10/03/2014	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s001ltr.pdf

Labels for NDA 204655

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204655Orig1s018lbl.pdf
04/04/2019	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204655Orig1s011lbl.pdf
01/24/2018	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204655Orig1s009lbl.pdf
02/03/2017	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204655Orig1s007lbl.pdf
01/09/2017	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204655Orig1s006lbl.pdf
06/02/2015	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204655Orig1s002lbl.pdf
10/03/2014	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s001lbl.pdf
03/28/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s000Lbl.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.

CAPSULE, 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	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	209716	AMNEAL PHARMS NY
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	216149	ANDA REPOSITORY
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	209339	AUROBINDO PHARMA
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	207198	DR REDDYS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	207673	DR REDDYS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	218092	GLENMARK SPECLT
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	216349	GRAVITI PHARMS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	212507	HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	207193	PERRIGO R AND D
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	212866	SUN PHARM
NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	Yes	204655	ASTRAZENECA LP

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