Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021689
Company: ASTRAZENECA
Company: ASTRAZENECA
| 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IV | ESOMEPRAZOLE SODIUM | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021689s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021689Orig1s038ltr.pdf | |
| 03/04/2022 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021689s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021689Orig1s037ltr.pdf | |
| 11/27/2020 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021689s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021689Orig1s035ltr.pdf | |
| 09/30/2019 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021689Orig1s034lbl.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021689Orig1s014.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 |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021689s038lbl.pdf | |
| 03/04/2022 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021689s037lbl.pdf | |
| 11/27/2020 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021689s035lbl.pdf | |
| 09/30/2019 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021689Orig1s034lbl.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 | 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 |