Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022020
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020987s060,022020s023lbl.pdf | |
| 03/04/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf | |
| 03/04/2022 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf | |
| 11/27/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf | |
| 04/25/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020987s055,022020s017lbl.pdf | |
| 06/07/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022020s016lbl.pdf | |
| 12/20/2017 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s051,022020s013lbl.pdf | |
| 12/06/2017 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf | |
| 07/06/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf | |
| 10/24/2016 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf | |
| 12/19/2014 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf | |
| 12/19/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf | |
| 12/10/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf | |
| 10/09/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf | |
| 05/11/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022020s007lbl.pdf | |
| 10/31/2011 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf | |
| 05/20/2011 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf | |
| 09/03/2010 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf | |
| 11/12/2009 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf | |
| 11/14/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022020lbl.pdf |