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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022020
Company: WYETH PHARMS

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 022020

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	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022020

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022020s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020_protonix_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2022	SUPPL-21	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020987Orig1s058; 022020Orig1s021ltr.pdf
11/27/2020	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020987Orig1s056;022020Orig1s018ltr.pdf
04/25/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020987s055,022020s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020987Orig1s055; 020988Orig1s061; 022020Orig1s017ltr.pdf
06/07/2018	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022020s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020987Orig1s054,022020Orig1s016,020988Orig1s060ltr.pdf
07/06/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Origs053,022020Orig1s015ltr.pdf
12/06/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022020s014, 020987s052, 020988s058ltr.pdf
12/20/2017	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s051,022020s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Orig1s051,020988Orig1s055,022020Orig1s013ltr.pdf
10/24/2016	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020987Orig1s050,022020Orig1s012ltr.pdf
12/19/2014	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022020Orig1s011,020987Orig1s049ltr.pdf
12/10/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020987Orig1s048,022020Orig1s010ltr.pdf
05/11/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022020s007lbl.pdf
10/09/2012	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020987Orig1s043,022020Orig1s006ltr.pdf
05/20/2011	SUPPL-5	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020987s041,022020s005ltr.pdf
10/31/2011	SUPPL-4	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022020s004,020987s039ltr.pdf
09/03/2010	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020987s038,022020s003ltr.pdf
11/12/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf

Labels for NDA 022020

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2022	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf
03/04/2022	SUPPL-21	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 022020

PROTONIX

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	217416	AJANTA PHARMA LTD
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	213725	SUN PHARM
PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022020	WYETH PHARMS

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