Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021153
Company: ASTRAZENECA
Company: ASTRAZENECA
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/20/2001 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21153lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021153s060,021957s027,022101s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021153Orig1s060;021957Orig1s027;022101Orig1s024ltr.pdf | |
| 03/04/2022 | SUPPL-59 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021153Orig1s059; 021957Orig1s026; 022101Orig1s023ltr.pdf | |
| 11/27/2020 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021153Orig1s057;021957Orig1s024;022101Orig1s021ltr.pdf | |
| 08/25/2021 | SUPPL-56 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021153s056,021957s023,022101s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021153Orig1s056, 021957Orig1s023, 022101Orig1s020ltr.pdf | |
| 06/07/2018 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021153Orig1s053,022101Orig1s017,021957Orig1s020ltr.pdf | |
| 10/24/2016 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf | |
| 12/20/2016 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021957Orig1s018,021153Orig1s051,022101Orig1s015ltr.pdf | |
| 12/19/2014 | SUPPL-50 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf | |
| 02/25/2014 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf | |
| 02/14/2014 | SUPPL-48 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021153Orig1s048.pdf |
| 10/04/2013 | SUPPL-47 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s047.pdf |
| 03/27/2014 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf | |
| 06/17/2013 | SUPPL-45 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s045.pdf |
| 11/28/2012 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf | |
| 09/28/2012 | SUPPL-43 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf | |
| 10/09/2012 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf | |
| 01/20/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf | |
| 06/30/2011 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf | |
| 09/03/2010 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf | |
| 06/21/2011 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf | |
| 03/04/2010 | SUPPL-34 | 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 | |
| 10/09/2009 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s033,022101s003ltr.pdf | |
| 01/15/2009 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf | |
| 01/11/2008 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021957s001,021153s029ltr.pdf |
| 04/27/2007 | SUPPL-28 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf | |
| 04/27/2007 | SUPPL-27 | 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-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s025ltr.pdf | |
| 09/15/2006 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s024ltr.pdf | |
| 10/11/2006 | SUPPL-23 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s023LTR.pdf | |
| 04/28/2006 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s022LTR.pdf | |
| 02/16/2006 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s021ltr.pdf | |
| 06/06/2005 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021153s020ltr.pdf | |
| 11/24/2004 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153s019ltr.pdf | |
| 04/23/2004 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153_S015_NEXIUM_DELAYED_RELEASE.pdf | |
| 01/09/2004 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr008_nexium_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153Orig1s008.pdf | |
| 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. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21153slr005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-153S005_review.pdf |
| 02/27/2003 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21153slr004ltr.pdf |
| 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. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021153s060,021957s027,022101s024lbl.pdf | |
| 03/04/2022 | SUPPL-59 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf | |
| 03/04/2022 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf | |
| 08/25/2021 | SUPPL-56 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021153s056,021957s023,022101s020lbl.pdf | |
| 08/25/2021 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021153s056,021957s023,022101s020lbl.pdf | |
| 11/27/2020 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf | |
| 06/07/2018 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf | |
| 12/20/2016 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf | |
| 10/24/2016 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf | |
| 12/19/2014 | SUPPL-50 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf | |
| 12/19/2014 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf | |
| 03/27/2014 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf | |
| 02/25/2014 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf | |
| 11/28/2012 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf | |
| 10/09/2012 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf | |
| 09/28/2012 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf | |
| 01/20/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf | |
| 06/30/2011 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf | |
| 06/21/2011 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf | |
| 09/03/2010 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf | |
| 03/04/2010 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf | |
| 10/09/2009 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf | |
| 01/15/2009 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf | |
| 04/27/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf | |
| 04/27/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf | |
| 10/11/2006 | SUPPL-23 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s023lbl.pdf | |
| 09/26/2006 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf | |
| 09/15/2006 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf | |
| 04/28/2006 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf | |
| 02/16/2006 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf | |
| 06/06/2005 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf | |
| 11/24/2004 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153s019lbl.pdf | |
| 04/23/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf | |
| 01/09/2004 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr008_nexium_lbl.pdf | |
| 02/20/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21153lbl.pdf |
NEXIUM
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 20MG BASE
TE Code = AB
| 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 | 209495 | GLENMARK PHARMS |
| 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 | 078003 | IVAX SUB TEVA PHARMS |
| 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 | 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 | 209735 | SUN PHARM |
| 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 |
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 40MG BASE
TE Code = AB
| 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 | 209495 | GLENMARK PHARMS |
| 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 | 078003 | IVAX SUB TEVA PHARMS |
| 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 | 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 | 209735 | SUN PHARM |
| 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 |