Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 021153
Company: ASTRAZENECA

Medication Guide

Other Important Information from FDA

Products on NDA 021153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	Yes	No
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	Yes	Yes

Showing 1 to 2 of 2 entries

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021153

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
02/20/2001	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY	Label (PDF) Letter (PDF) Review

Showing 1 to 1 of 1 entries

Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
07/18/2023	SUPPL-60	Labeling-Package Insert	Label (PDF) Letter (PDF)
03/04/2022	SUPPL-59	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)
08/25/2021	SUPPL-56	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)
11/27/2020	SUPPL-57	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/07/2018	SUPPL-53	Labeling-Package Insert	Label (PDF) Letter (PDF)
12/20/2016	SUPPL-51	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/24/2016	SUPPL-52	Labeling-Package Insert	Label (PDF) Letter (PDF)
12/19/2014	SUPPL-50	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)
03/27/2014	SUPPL-46	Labeling-Package Insert	Label (PDF) Letter (PDF)
02/25/2014	SUPPL-49	Labeling-Package Insert	Label (PDF) Letter (PDF)
02/14/2014	SUPPL-48	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.
10/04/2013	SUPPL-47	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.
06/17/2013	SUPPL-45	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.
11/28/2012	SUPPL-44	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/09/2012	SUPPL-42	Labeling-Package Insert	Label (PDF) Letter (PDF)
09/28/2012	SUPPL-43	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)
01/20/2012	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/30/2011	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/21/2011	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)
09/03/2010	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)
03/04/2010	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/09/2009	SUPPL-33	Labeling	Label (PDF) Letter (PDF)
01/15/2009	SUPPL-31	Labeling	Label (PDF) Letter (PDF)
01/11/2008	SUPPL-29	Labeling	Letter (PDF)	Label is not available on this site.
04/27/2007	SUPPL-28	Labeling	Label (PDF)
04/27/2007	SUPPL-27	Labeling	Label (PDF) Letter (PDF)
10/11/2006	SUPPL-23	Efficacy-New Indication	Label (PDF) Letter (PDF)
09/26/2006	SUPPL-25	Labeling	Label (PDF) Letter (PDF)
09/15/2006	SUPPL-24	Labeling	Label (PDF) Letter (PDF)
04/28/2006	SUPPL-22	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
02/16/2006	SUPPL-21	Labeling	Label (PDF) Letter (PDF)
06/06/2005	SUPPL-20	Labeling	Label (PDF) Letter (PDF)
11/24/2004	SUPPL-19	Efficacy-New Indication	Label (PDF) Letter (PDF)
04/23/2004	SUPPL-15	Labeling	Label (PDF) Letter (PDF) Review (PDF)
01/09/2004	SUPPL-8	Labeling	Label (PDF) Letter (PDF) Review (PDF)
02/27/2003	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.
10/01/2002	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/20/2002	SUPPL-5	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.
03/14/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/16/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/16/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Showing 1 to 41 of 41 entries

Labels for NDA 021153

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert
07/18/2023	SUPPL-60	Labeling-Package Insert	Label (PDF)
03/04/2022	SUPPL-59	Labeling-Package Insert	Label (PDF)
03/04/2022	SUPPL-59	Labeling-Medication Guide	Label (PDF)
08/25/2021	SUPPL-56	Labeling-Container/Carton Labels	Label (PDF)
08/25/2021	SUPPL-56	Labeling-Package Insert	Label (PDF)
11/27/2020	SUPPL-57	Labeling-Package Insert	Label (PDF)
06/07/2018	SUPPL-53	Labeling-Package Insert	Label (PDF)
12/20/2016	SUPPL-51	Labeling-Package Insert	Label (PDF)
10/24/2016	SUPPL-52	Labeling-Package Insert	Label (PDF)
12/19/2014	SUPPL-50	Labeling-Medication Guide	Label (PDF)
12/19/2014	SUPPL-50	Labeling-Package Insert	Label (PDF)
03/27/2014	SUPPL-46	Labeling-Package Insert	Label (PDF)
02/25/2014	SUPPL-49	Labeling-Package Insert	Label (PDF)
11/28/2012	SUPPL-44	Labeling-Package Insert	Label (PDF)
10/09/2012	SUPPL-42	Labeling-Package Insert	Label (PDF)
09/28/2012	SUPPL-43	Labeling-Container/Carton Labels	Label (PDF)
01/20/2012	SUPPL-40	Labeling-Package Insert	Label (PDF)
06/30/2011	SUPPL-38	Labeling-Package Insert	Label (PDF)
06/21/2011	SUPPL-35	Labeling-Package Insert	Label (PDF)
09/03/2010	SUPPL-36	Labeling-Package Insert	Label (PDF)
03/04/2010	SUPPL-34	Labeling-Package Insert	Label (PDF)
10/09/2009	SUPPL-33	Labeling	Label (PDF)
01/15/2009	SUPPL-31	Labeling	Label (PDF)
04/27/2007	SUPPL-28	Labeling	Label (PDF)
04/27/2007	SUPPL-27	Labeling	Label (PDF)
10/11/2006	SUPPL-23	Efficacy-New Indication	Label (PDF)
09/26/2006	SUPPL-25	Labeling	Label (PDF)
09/15/2006	SUPPL-24	Labeling	Label (PDF)
04/28/2006	SUPPL-22	Efficacy-New Patient Population	Label (PDF)
02/16/2006	SUPPL-21	Labeling	Label (PDF)
06/06/2005	SUPPL-20	Labeling	Label (PDF)
11/24/2004	SUPPL-19	Efficacy-New Indication	Label (PDF)
04/23/2004	SUPPL-15	Labeling	Label (PDF)
01/09/2004	SUPPL-8	Labeling	Label (PDF)
02/20/2001	ORIG-1	Approval	Label (PDF)

Showing 1 to 35 of 35 entries

Therapeutic Equivalents for NDA 021153

NEXIUM

CAPSULE, DELAYED REL PELLETS;ORAL; EQ 20MG BASE
TE Code = AB

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	208333	ALKEM LABS LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	205606	AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	213158	CISEN
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	212949	CSPC OUYI
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	078279	DR REDDYS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	090841	ETHYPHARM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	217427	GRANULES
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	213486	GRAVITI PHARMS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	213859	GUANGZHOU NOVAKEN
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	211977	HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	210559	INDCHEMIE HEALTH
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	205563	LANNETT CO INC
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	208511	MACLEODS PHARMS LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	078936	MYLAN
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	214920	PRINSTON INC
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	217022	ZHEJIANG YONGTAI
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	206296	ZYDUS PHARMS
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	Yes	AB	021153	ASTRAZENECA

Showing 1 to 18 of 18 entries

CAPSULE, DELAYED REL PELLETS;ORAL; EQ 40MG BASE
TE Code = AB

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	208333	ALKEM LABS LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	205606	AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	213158	CISEN
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	212949	CSPC OUYI
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	078279	DR REDDYS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	090841	ETHYPHARM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	217427	GRANULES
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	213486	GRAVITI PHARMS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	213859	GUANGZHOU NOVAKEN
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	211977	HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	210559	INDCHEMIE HEALTH
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	205563	LANNETT CO INC
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	208511	MACLEODS PHARMS LTD
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	078936	MYLAN
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	214920	PRINSTON INC
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	217022	ZHEJIANG YONGTAI
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	206296	ZYDUS PHARMS
NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	Yes	AB	021153	ASTRAZENECA

Showing 1 to 18 of 18 entries