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FDA NDA · NDA019810

PRILOSEC

Sponsor: ASTRAZENECA

APPLICATION
NDA019810
TYPE
NDA
ORIGINAL APPROVAL
1989-09-14
LATEST ACTION
2016-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued

Products

PRILOSEC · ReferenceDiscontinued
OMEPRAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED REL PELLETS · ORAL
PRILOSEC · ReferenceDiscontinued
OMEPRAZOLE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED REL PELLETS · ORAL
PRILOSEC · ReferenceDiscontinued
OMEPRAZOLE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2016-12-19Labeling · Supplement 102 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 103 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 101 · 901 required — Label ↗AP
2014-03-27Labeling · Supplement 98 · standard — Letter ↗AP
2014-02-25Labeling · Supplement 99 · 901 required — Letter ↗AP
2013-05-15Labeling · Supplement 97 · standard — Label ↗AP
2012-10-09Labeling · Supplement 95 · standard — Letter ↗AP
2012-09-28Labeling · Supplement 96 · standard — Label ↗AP
2012-01-20Labeling · Supplement 94 · unknown — Letter ↗AP
2011-06-30Labeling · Supplement 91 · unknown — Label ↗AP
2011-05-20Labeling · Supplement 93 · 901 required — Label ↗AP
2011-01-20Labeling · Supplement 92 · unknown — Label ↗AP
2010-09-03Labeling · Supplement 90 · unknown — Letter ↗AP
2010-03-03Labeling · Supplement 88 · unknown — Letter ↗AP
2008-12-01Labeling · Supplement 87 · standard — Label ↗AP
2007-04-27Labeling · Supplement 85 · standard — Label ↗AP
2006-09-25Labeling · Supplement 84 · standard — Letter ↗AP
2006-01-26Labeling · Supplement 83 · standard — Letter ↗AP
2005-03-07Labeling · Supplement 82 · standard — Letter ↗AP
2004-02-23Labeling · Supplement 3 — Letter ↗AP
2004-02-23Efficacy · Supplement 58 · standard — Letter ↗AP
2003-10-09Labeling · Supplement 80 · standard — Letter ↗AP
2003-10-09Labeling · Supplement 67 · standard — Letter ↗AP
2002-12-19Manufacturing (CMC) · Supplement 77 · priorityAP
2002-12-16Labeling · Supplement 76 · standard — Letter ↗AP
2002-07-12Efficacy · Supplement 74 · standard — Letter ↗AP
2002-02-14Efficacy · Supplement 61 · standard — Letter ↗AP
2002-02-04Manufacturing (CMC) · Supplement 71 · priorityAP
2001-10-30Labeling · Supplement 73 · standardAP
2001-05-16Manufacturing (CMC) · Supplement 66 · priorityAP
2001-05-10Manufacturing (CMC) · Supplement 75 · priorityAP
2000-08-10Manufacturing (CMC) · Supplement 72 · priorityAP
2000-08-08Manufacturing (CMC) · Supplement 63 · priorityAP
2000-07-27Manufacturing (CMC) · Supplement 70 · priorityAP
2000-07-27Manufacturing (CMC) · Supplement 69 · priorityAP
2000-03-16Manufacturing (CMC) · Supplement 64 · priorityAP
2000-03-13Manufacturing (CMC) · Supplement 59 · priorityAP
2000-03-13Manufacturing (CMC) · Supplement 68 · priorityAP
2000-02-23Labeling · Supplement 62 · standard — Review ↗AP
1999-11-10Manufacturing (CMC) · Supplement 65 · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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