Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021849
Company: SALIX
Company: SALIX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/27/2006 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021849s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021849s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021849TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021849s020,021636s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021636Orig1s025;021849Orig1s020ltr.pdf | |
| 03/04/2022 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021636Orig1s024; 021849Orig1s019ltr.pdf | |
| 03/16/2021 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021849Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021849Orig1s017ltr.pdf | |
| 11/27/2020 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021636s022,021849s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021636Orig1s022;021849Orig1s016ltr.pdf | |
| 09/24/2019 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021636s020,021849s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021636Orig1s020,%20021849Orig1s015ltr.pdf | |
| 06/07/2018 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021849Orig1s014,021636Orig1s019ltr.pdf | |
| 10/24/2016 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf | |
| 06/01/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf | |
| 02/25/2014 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf | |
| 04/19/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf | |
| 11/09/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf | |
| 12/07/2011 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf | |
| 05/20/2011 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf | |
| 09/03/2010 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf | |
| 01/20/2010 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf |
| 12/21/2007 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021849s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021849s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021849Orig1s002.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021849s020,021636s025lbl.pdf | |
| 03/04/2022 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf | |
| 03/04/2022 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf | |
| 03/16/2021 | SUPPL-17 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021849Orig1s017lbl.pdf | |
| 11/27/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021636s022,021849s016lbl.pdf | |
| 09/24/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021636s020,021849s015lbl.pdf | |
| 09/24/2019 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021636s020,021849s015lbl.pdf | |
| 06/07/2018 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf | |
| 06/07/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf | |
| 10/24/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf | |
| 12/19/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf | |
| 12/19/2014 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf | |
| 02/25/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf | |
| 11/09/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf | |
| 04/19/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf | |
| 12/07/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf | |
| 05/20/2011 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf | |
| 09/03/2010 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf | |
| 12/21/2007 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021849s002lbl.pdf | |
| 12/21/2007 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021849s002lbl.pdf | |
| 02/27/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021849s000lbl.pdf |