Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021689
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEXIUM IV ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No
NEXIUM IV ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/31/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021689lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021689ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021689s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2019 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021689s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021689Orig1s034ltr.pdf
08/10/2018 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021689s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021689Orig1s033ltr.pdf
10/24/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021689Orig1s032ltr.pdf
12/19/2016 SUPPL-31 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021689Orig1s031ltr.pdf
12/19/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s030ltr.pdf
10/20/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/25/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s028ltr.pdf
03/27/2014 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s027ltr.pdf
09/28/2012 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s026ltr.pdf
10/09/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s025ltr.pdf
01/20/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689s022ltr.pdf
06/30/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf
09/03/2010 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021689s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021689s018ltr.pdf
04/29/2011 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021689s017ltr.pdf
06/21/2011 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf
03/04/2010 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf
03/04/2014 SUPPL-14 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s014ltr.pdf
01/15/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021689s012,021689s013ltr.pdf
01/15/2009 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021689s012,021689s013ltr.pdf
04/27/2007 SUPPL-11 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf
04/27/2007 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021153s027, 021689s008ltr.pdf
09/26/2006 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s007ltr.pdf
09/15/2006 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s006ltr.pdf
02/16/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689S003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s003ltr.pdf
01/12/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/2019 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021689s034lbl.pdf
08/10/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021689s033lbl.pdf
12/19/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s031lbl.pdf
12/19/2016 SUPPL-31 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s031lbl.pdf
10/24/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s032lbl.pdf
12/19/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s030lbl.pdf
03/27/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s027lbl.pdf
03/04/2014 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s014lbl.pdf
02/25/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s028lbl.pdf
10/09/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s025lbl.pdf
09/28/2012 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s026lbl.pdf
01/20/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s022lbl.pdf
06/30/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s020lbl.pdf
06/21/2011 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s016lbl.pdf
04/29/2011 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s017lbl.pdf
09/03/2010 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021689s018lbl.pdf
03/04/2010 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf
01/15/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf
01/15/2009 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf
04/27/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf
04/27/2007 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf
09/26/2006 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s007lbl.pdf
09/15/2006 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s006lbl.pdf
02/16/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689S003lbl.pdf
01/12/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s002lbl.pdf
03/31/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021689lbl.pdf

NEXIUM IV

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 204657 AUROBINDO PHARMA LTD
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 202686 MYLAN LABS LTD
ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 200882 SUN PHARMA GLOBAL
NEXIUM IV ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 021689 ASTRAZENECA PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English