Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022511
Company: HORIZON
Company: HORIZON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIMOVO | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| VIMOVO | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/30/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022511lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022511s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022511s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022511Orig1s029ltr.pdf | |
| 03/04/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022511s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022511Orig1s028ltr.pdf | |
| 04/28/2021 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022511s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022511Orig1s026ltr.pdf | |
| 11/27/2020 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022511s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022511Orig1s025ltr.pdf | |
| 07/22/2019 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022511s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022511Orig1s024ltr.pdf | |
| 06/07/2018 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022511Orig1s023ltr.pdf | |
| 10/24/2016 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s020ltr.pdf | |
| 07/06/2017 | SUPPL-19 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022511s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022511Orig1s019ltr.pdf | |
| 05/09/2016 | SUPPL-18 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s018ltr.pdf | |
| 12/19/2014 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s017ltr.pdf | |
| 06/19/2015 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s016ltr.pdf | |
| 03/25/2015 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s015ltr.pdf | |
| 08/27/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2014 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s012ltr.pdf | |
| 03/20/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2014 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s010ltr.pdf | |
| 06/12/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s008ltr.pdf | |
| 09/28/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s007ltr.pdf | |
| 01/20/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511s006ltr.pdf | |
| 05/20/2011 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s004ltr.pdf | |
| 06/21/2011 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf | |
| 06/21/2011 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf | |
| 11/18/2011 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022511s029lbl.pdf | |
| 03/04/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022511s028lbl.pdf | |
| 04/28/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022511s026lbl.pdf | |
| 11/27/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022511s025lbl.pdf | |
| 07/22/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022511s024lbl.pdf | |
| 06/07/2018 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf | |
| 06/07/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf | |
| 07/06/2017 | SUPPL-19 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022511s019lbl.pdf | |
| 10/24/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s020lbl.pdf | |
| 05/09/2016 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s018lbl.pdf | |
| 06/19/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s016lbl.pdf | |
| 03/25/2015 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s015lbl.pdf | |
| 12/19/2014 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s017lbl.pdf | |
| 03/27/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s010lbl.pdf | |
| 02/25/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s012lbl.pdf | |
| 10/09/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008lbl.pdf | |
| 09/28/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007lbl.pdf | |
| 01/20/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s006lbl.pdf | |
| 11/18/2011 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s001lbl.pdf | |
| 06/21/2011 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf | |
| 06/21/2011 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf | |
| 05/20/2011 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s004lbl.pdf | |
| 04/30/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022511lbl.pdf |