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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020987
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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf
12/19/2014 SUPPL-49 Labeling-Package Insert 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
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