← FDA DRUG APPROVALS

FDA NDA · NDA022020

PROTONIX DELAYED-RELEASE

pantoprazole sodium

Sponsor: WYETH PHARMS

APPLICATION
NDA022020
TYPE
NDA
ORIGINAL APPROVAL
2007-11-14
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PROTONIX · ReferencePrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE · FOR SUSPENSION, DELAYED RELEASE · ORAL

Approval history

2023-07-18Labeling · Supplement 23 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 21 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 18 · standard — Letter ↗AP
2019-04-25Labeling · Supplement 17 · standard — Letter ↗AP
2018-06-07Labeling · Supplement 16 · standard — Label ↗AP
2017-12-20Labeling · Supplement 13 · standard — Label ↗AP
2017-12-06Labeling · Supplement 14 · standard — Label ↗AP
2017-07-06Labeling · Supplement 15 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 12 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 11 · 901 required — Label ↗AP
2013-12-10Labeling · Supplement 10 · standard — Label ↗AP
2012-10-09Labeling · Supplement 6 · standard — Label ↗AP
2012-05-11Labeling · Supplement 7 · standard — Label ↗AP
2011-10-31Labeling · Supplement 4 · unknown — Label ↗AP
2011-05-20Labeling · Supplement 5 · unknown — Letter ↗AP
2010-09-03Labeling · Supplement 3 · 901 required — Letter ↗AP
2009-11-12Labeling · Supplement 2 · standard — Label ↗AP
2007-11-14Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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