← FDA DRUG APPROVALS

FDA NDA · NDA020987

PROTONIX DELAYED-RELEASE

pantoprazole sodium

Sponsor: WYETH PHARMS

APPLICATION
NDA020987
TYPE
NDA
ORIGINAL APPROVAL
2000-02-02
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PROTONIX · ReferencePrescription
PANTOPRAZOLE SODIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
PROTONIX · ReferencePrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2023-07-18Labeling · Supplement 60 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 58 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 56 · standard — Letter ↗AP
2019-04-25Labeling · Supplement 55 · standard — Letter ↗AP
2018-06-07Labeling · Supplement 54 · standard — Label ↗AP
2017-12-20Labeling · Supplement 51 · standard — Label ↗AP
2017-12-06Labeling · Supplement 52 · standard — Label ↗AP
2017-07-06Labeling · Supplement 53 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 50 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 49 · 901 required — Label ↗AP
2013-12-10Labeling · Supplement 48 · standard — Letter ↗AP
2013-01-25Manufacturing (CMC) · Supplement 46 · standardAP
2012-10-09Labeling · Supplement 43 · standard — Label ↗AP
2012-05-11Labeling · Supplement 45 · standard — Label ↗AP
2011-10-31Labeling · Supplement 39 · unknown — Letter ↗AP
2011-05-20Labeling · Supplement 41 · unknown — Letter ↗AP
2010-09-03Labeling · Supplement 38 · 901 required — Letter ↗AP
2009-11-12Labeling · Supplement 37 · standard — Letter ↗AP
2009-11-12Efficacy · Supplement 36 · standard — Letter ↗AP
2007-12-20Labeling · Supplement 35 · standard — Letter ↗AP
2006-07-25Labeling · Supplement 32 · standard — Letter ↗AP
2004-11-18Labeling · Supplement 26 · standard — Letter ↗AP
2004-05-05Labeling · Supplement 20 · standard — Letter ↗AP
2004-03-12Labeling · Supplement 23 · standard — Label ↗AP
2004-03-05Labeling · Supplement 17 · standard — Label ↗AP
2004-01-09Labeling · Supplement 22 · standard — Letter ↗AP
2003-12-30Labeling · Supplement 21 · standard — Letter ↗AP
2002-12-06Manufacturing (CMC) · Supplement 14 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 16 · standardAP
2002-12-03Manufacturing (CMC) · Supplement 15 · standardAP
2002-10-28Labeling · Supplement 13 · standard — Letter ↗AP
2002-09-05Manufacturing (CMC) · Supplement 11 · standardAP
2002-07-22Manufacturing (CMC) · Supplement 12 · standardAP
2002-07-02Manufacturing (CMC) · Supplement 9 · standardAP
2002-06-12Manufacturing (CMC) · Supplement 6 · standardAP
2002-05-14Manufacturing (CMC) · Supplement 10 · standardAP
2002-04-19Efficacy · Supplement 7 · standard — Letter ↗AP
2002-03-12Manufacturing (CMC) · Supplement 8 · standardAP
2001-07-20Labeling · Supplement 5 · standard — Label ↗AP
2001-06-12Efficacy · Supplement 1 · standard — Letter ↗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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