← FDA DRUG APPROVALS

FDA NDA · NDA021428

PREVACID SOLUTAB

lansoprazole

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021428
TYPE
NDA
ORIGINAL APPROVAL
2002-08-30
LATEST ACTION
2023-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PREVACID · ReferencePrescription
LANSOPRAZOLE 30MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL
PREVACID · ReferencePrescription
LANSOPRAZOLE 15MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL

Approval history

2023-08-08Labeling · Supplement 42 · standard — Label ↗AP
2022-03-04Labeling · Supplement 41 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 39 · standard — Letter ↗AP
2020-09-11Labeling · Supplement 37 · standard — Letter ↗AP
2018-06-07Labeling · Supplement 35 · standard — Label ↗AP
2018-06-07Labeling · Supplement 34 · standard — Label ↗AP
2018-04-13Labeling · Supplement 32 · standard — Letter ↗AP
2017-10-18Labeling · Supplement 31 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 30 · standard — Letter ↗AP
2015-12-16Labeling · Supplement 27 · standard — Label ↗AP
2014-12-19Labeling · Supplement 28 · 901 required — Letter ↗AP
2012-09-28Labeling · Supplement 25 · standard — Label ↗AP
2012-05-03Labeling · Supplement 26 · standard — Letter ↗AP
2011-10-28Labeling · Supplement 23 · unknown — Label ↗AP
2011-06-01Labeling · Supplement 22 · standard — Label ↗AP
2011-05-20Labeling · Supplement 24 · 901 required — Label ↗AP
2010-09-03Labeling · Supplement 21 · unknown — Label ↗AP
2010-05-12Labeling · Supplement 20 · unknown — Label ↗AP
2009-07-31Labeling · Supplement 19 · standard — Label ↗AP
2008-10-28Efficacy · Supplement 17 · priority — Label ↗AP
2008-04-21Labeling · Supplement 13 · standard — Letter ↗AP
2007-06-14Labeling · Supplement 12 · standard — Letter ↗AP
2006-04-12Labeling · Supplement 6 · standard — Label ↗AP
2004-06-17Efficacy · Supplement 4 · priority — Label ↗AP
2004-06-15Labeling · Supplement 3 · standardAP
2003-08-05Labeling · Supplement 1 · standard — Letter ↗AP
2002-08-30Type 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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