← FDA DRUG APPROVALS

FDA NDA · NDA020406

PREVACID

lansoprazole

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA020406
TYPE
NDA
ORIGINAL APPROVAL
1995-05-10
LATEST ACTION
2023-08-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued, Prescription

Products

PREVACID · ReferenceDiscontinued
LANSOPRAZOLE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED REL PELLETS · ORAL
PREVACID · ReferencePrescription
LANSOPRAZOLE 30MG · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2023-08-08Labeling · Supplement 95 · standardLetterAP
2022-03-04Labeling · Supplement 94 · standardLetterAP
2020-11-27Labeling · Supplement 92 · standardLetterAP
2020-09-11Labeling · Supplement 90 · standardLetterAP
2018-06-07Labeling · Supplement 87 · standardLabelAP
2018-06-07Labeling · Supplement 88 · standardLabelAP
2018-04-13Labeling · Supplement 84 · standardLetterAP
2017-10-18Labeling · Supplement 83 · standardLetterAP
2016-10-24Labeling · Supplement 82 · standardLetterAP
2015-12-16Labeling · Supplement 80 · standardLabelAP
2014-12-19Labeling · Supplement 81 · 901 requiredLetterAP
2012-09-28Labeling · Supplement 78 · standardLabelAP
2012-05-03Labeling · Supplement 79 · standardLetterAP
2011-10-28Labeling · Supplement 76 · standardLabelAP
2011-06-01Labeling · Supplement 75 · standardLetterAP
2011-05-20Labeling · Supplement 77 · 901 requiredLetterAP
2010-09-03Labeling · Supplement 74 · unknownLabelAP
2010-05-12Labeling · Supplement 73 · unknownLetterAP
2009-07-31Labeling · Supplement 71 · standardLetterAP
2008-10-28Efficacy · Supplement 67 · priorityPediatric Written RequestAP
2008-09-08Manufacturing (CMC) · Supplement 68AP
2008-04-21Labeling · Supplement 65 · standardLetterAP
2007-06-14Labeling · Supplement 64 · standardLabelAP
2006-04-12Labeling · Supplement 58 · standardLetterAP
2004-06-17Efficacy · Supplement 57 · priorityLabelAP
2004-06-15Labeling · Supplement 56 · standardLetterAP
2003-08-05Labeling · Supplement 55 · standardLetterAP
2002-12-03Labeling · Supplement 48 · standardReviewAP
2002-08-30Labeling · Supplement 52 · standardReviewAP
2002-07-31Efficacy · Supplement 47 · priorityLabelAP
2002-05-03Labeling · Supplement 45 · standardLetterAP
2002-03-07Manufacturing (CMC) · Supplement 46 · standardAP
2001-12-05Manufacturing (CMC) · Supplement 44 · standardReviewAP
2001-06-29Manufacturing (CMC) · Supplement 41 · standardReviewAP
2001-05-07Manufacturing (CMC) · Supplement 40 · standardAP
2001-05-01Efficacy · Supplement 38 · standardLetterAP
2001-04-11Manufacturing (CMC) · Supplement 43 · standardReviewAP
2000-12-08Manufacturing (CMC) · Supplement 42 · standardAP
2000-11-30Efficacy · Supplement 33 · unknownLetterAP
2000-10-30Manufacturing (CMC) · Supplement 39 · standardReviewAP
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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