← FDA DRUG APPROVALS

FDA NDA · NDA020973

ACIPHEX

rabeprazole sodium

Sponsor: WAYLIS THERAP

APPLICATION
NDA020973
TYPE
NDA
ORIGINAL APPROVAL
1999-08-19
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued, Prescription

Products

ACIPHEX · ReferenceDiscontinued
RABEPRAZOLE SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
ACIPHEX · ReferencePrescription
RABEPRAZOLE SODIUM 20MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2023-07-18Labeling · Supplement 43 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 42 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 41 · standard — Letter ↗AP
2018-06-07Labeling · Supplement 39 · standard — Label ↗AP
2018-01-09Labeling · Supplement 38 · standard — Label ↗AP
2016-10-24Labeling · Supplement 37 · standard — Letter ↗AP
2016-04-04Labeling · Supplement 33 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 35 · 901 required — Letter ↗AP
2014-10-15Labeling · Supplement 34 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 32 · standard — Label ↗AP
2012-10-05Labeling · Supplement 29 · 901 required — Letter ↗AP
2012-05-08Labeling · Supplement 30 · standard — Label ↗AP
2011-05-20Labeling · Supplement 28 · 901 required — Label ↗AP
2010-09-03Labeling · Supplement 25 · unknown — Label ↗AP
2008-06-30Efficacy · Supplement 22 · unknown — Letter ↗AP
2005-06-03Labeling · Supplement 20 · standard — Letter ↗AP
2003-08-01Labeling · Supplement 16 · standard — Letter ↗AP
2002-11-08Efficacy · Supplement 13 · standard — Review ↗AP
2002-09-30Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP
2002-09-23Labeling · Supplement 14 · standard — Letter ↗AP
2002-05-29Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
2002-02-12Efficacy · Supplement 9 · standard — Label ↗AP
2001-10-02Manufacturing (CMC) · Supplement 10 · standardAP
2001-10-02Manufacturing (CMC) · Supplement 11 · standardAP
2001-08-15Labeling · Supplement 8 · standard — Review ↗AP
2000-12-15Manufacturing (CMC) · Supplement 7 · standardAP
2000-09-20Manufacturing (CMC) · Supplement 6 · standardAP
2000-05-08Manufacturing (CMC) · Supplement 4 · standardAP
2000-02-28Manufacturing (CMC) · Supplement 5 · standardAP
2000-02-16Manufacturing (CMC) · Supplement 2 · standardAP
2000-02-16Manufacturing (CMC) · Supplement 3 · standardAP
1999-10-21Manufacturing (CMC) · Supplement 1 · standardAP
1999-08-19Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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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