Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020988
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTONIX IV PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription AP 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
12/06/2004 ORIG-27 Approval Supplement STANDARD

Label is not available on this site.

03/22/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/06/2017 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020988s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020988Orig1s059ltr.pdf
10/24/2016 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020988s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/20988Orig1s054ltr.pdf
11/09/2015 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

12/19/2014 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020988s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020988Orig1s052ltr.pdf
11/05/2014 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020988s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020988Orig1s048ltr.pdf
03/04/2014 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/10/2012 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988s045ltr.pdf
09/28/2012 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988Orig1s044ltr.pdf
05/20/2011 SUPPL-43 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s043ltr.pdf
12/07/2011 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s042ltr.pdf
06/07/2011 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s041ltr.pdf
09/03/2010 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020988s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020988s040ltr.pdf
12/20/2007 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020987s035,020988s038rev2_dw.pdf
08/03/2005 SUPPL-32 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s032ltr.pdf
08/02/2005 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s031ltr.pdf
10/28/2004 SUPPL-29 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s029ltr.pdf
11/18/2004 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s028ltr.pdf
12/06/2004 SUPPL-27 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s027ltr.pdf
04/02/2004 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr025ltr.pdf
04/02/2004 SUPPL-24 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988scf024_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988scf024ltr.pdf
01/02/2004 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr021ltr.pdf
01/09/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr020_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr020ltr.pdf
05/05/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr019ltr.pdf
11/18/2003 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20988slr017_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr017ltr.pdf
10/24/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr016ltr.pdf
03/05/2004 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr015_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr015ltr.pdf
12/04/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/28/2002 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr012ltr.pdf
05/14/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/18/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2003 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr007ltr.pdf
06/08/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-4 Labeling

Label is not available on this site.

10/19/2001 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20988s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20988s3ltr.pdf
09/27/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/15/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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/2004/20988s027lbl.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

PROTONIX IV

INJECTABLE;IV (INFUSION); EQ 40MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 079197 AKORN INC
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 205675 AUROBINDO PHARMA LTD
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 090296 SANDOZ INC
PROTONIX IV PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription Yes AP 020988 WYETH PHARMS INC

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