Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020987
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 | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| 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/2023/020987s060,022020s023lbl.pdf | |
| 03/04/2022 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf | |
| 11/27/2020 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf | |
| 04/25/2019 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020987s055,022020s017lbl.pdf | |
| 06/07/2018 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020987s054lbl.pdf | |
| 12/20/2017 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s051,022020s013lbl.pdf | |
| 12/06/2017 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf | |
| 07/06/2017 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf | |
| 10/24/2016 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf | |
| 12/19/2014 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf | |
| 12/19/2014 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf | |
| 12/10/2013 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf | |
| 10/09/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf | |
| 05/11/2012 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s045lbl.pdf | |
| 10/31/2011 | SUPPL-39 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf | |
| 05/20/2011 | SUPPL-41 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf | |
| 09/03/2010 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf | |
| 11/12/2009 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf | |
| 11/12/2009 | SUPPL-36 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf | |
| 05/05/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr020_protonix_lbl.pdf | |
| 03/12/2004 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf | |
| 03/05/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf | |
| 01/09/2004 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr022_protonix_lbl.pdf | |
| 04/19/2002 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20987s7lbl.pdf | |
| 07/20/2001 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20987s5lbl.pdf | |
| 06/12/2001 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/020987S1S2lbl.pdf | |
| 02/02/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf |