Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022056
Company: COVIS
Company: COVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRILOSEC | OMEPRAZOLE MAGNESIUM | EQ 2.5MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | None | Yes | No |
| PRILOSEC | OMEPRAZOLE MAGNESIUM | EQ 10MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 03/20/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022056s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056_prilosec_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022056s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022056Orig1s026ltr.pdf | |
| 03/04/2022 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022056s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022056Orig1s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022056Orig1s025ltr.pdf | |
| 11/27/2020 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022056s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022056Orig1s023ltr.pdf | |
| 06/07/2018 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022056Orig1s022ltr.pdf | |
| 08/21/2018 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022056Orig1s021ltr.pdf | |
| 10/24/2016 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf | |
| 12/19/2016 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s102,022056Orig1s019ltr.pdf | |
| 02/03/2016 | SUPPL-18 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022056s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022056Orig1s018ltr.pdf | |
| 12/19/2014 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf | |
| 02/25/2014 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf | |
| 03/27/2014 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf | |
| 05/15/2013 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf | |
| 09/28/2012 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf | |
| 10/09/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf | |
| 01/20/2012 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf | |
| 05/20/2011 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf | |
| 01/20/2011 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf | |
| 06/30/2011 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf | |
| 09/03/2010 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf | |
| 03/03/2010 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf | |
| 12/01/2008 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022056s026lbl.pdf | |
| 07/18/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022056s026lbl.pdf | |
| 03/04/2022 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022056s025lbl.pdf | |
| 03/04/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022056s025lbl.pdf | |
| 11/27/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022056s023lbl.pdf | |
| 08/21/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s021lbl.pdf | |
| 06/07/2018 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s022lbl.pdf | |
| 06/07/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s022lbl.pdf | |
| 12/19/2016 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf | |
| 10/24/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf | |
| 02/03/2016 | SUPPL-18 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022056s018lbl.pdf | |
| 12/19/2014 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf | |
| 12/19/2014 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf | |
| 03/27/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf | |
| 02/25/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf | |
| 05/15/2013 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf | |
| 10/09/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf | |
| 09/28/2012 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf | |
| 01/20/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf | |
| 06/30/2011 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf | |
| 05/20/2011 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf | |
| 01/20/2011 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf | |
| 09/03/2010 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf | |
| 03/03/2010 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf | |
| 12/01/2008 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf | |
| 03/20/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf |