Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020988
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTONIX IV | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/12/2024 | SUPPL-70 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020988s070lbl.pdf | |
| 07/18/2023 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020988s069lbl.pdf | |
| 03/04/2022 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020988s064lbl.pdf | |
| 11/27/2020 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020988s062lbl.pdf | |
| 04/25/2019 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020988s061lbl.pdf | |
| 06/07/2018 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020988s060lbl.pdf | |
| 12/20/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s055lbl.pdf | |
| 12/06/2017 | SUPPL-58 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf | |
| 07/06/2017 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s059lbl.pdf | |
| 10/24/2016 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020988s054lbl.pdf | |
| 12/19/2014 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020988s052lbl.pdf | |
| 12/12/2013 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020988s048lbl.pdf | |
| 09/28/2012 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s044lbl.pdf | |
| 05/10/2012 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf | |
| 12/07/2011 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s042lbl.pdf | |
| 06/07/2011 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf | |
| 05/20/2011 | SUPPL-43 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s043lbl.pdf | |
| 09/03/2010 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020988s040lbl.pdf | |
| 08/03/2005 | SUPPL-32 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf |
| 08/02/2005 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s031lbl.pdf | |
| 12/06/2004 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020988Orig1s027s070lbl.pdf | |
| 05/05/2004 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.pdf | |
| 04/02/2004 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.pdf | |
| 04/02/2004 | SUPPL-24 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988scf024_protonix_lbl.pdf | |
| 03/05/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr015_protonix_lbl.pdf | |
| 01/09/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr020_protonix_lbl.pdf | |
| 11/18/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20988slr017_protonix_lbl.pdf | |
| 10/19/2001 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20988s3lbl.pdf | |
| 03/22/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_prntlbl.pdf |