← FDA DRUG APPROVALS

FDA NDA · NDA022327

PREVACID 24 HR

Sponsor: PERRIGO PHARMA INTL

APPLICATION
NDA022327
TYPE
NDA
ORIGINAL APPROVAL
2009-05-18
LATEST ACTION
2022-12-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Over-the-counter

Products

PREVACID 24 HR · ReferenceOver-the-counter
LANSOPRAZOLE 15MG · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2022-12-29Labeling · Supplement 31 · standard — Letter ↗AP
2022-06-23Labeling · Supplement 30 · standard — Letter ↗AP
2022-03-01Labeling · Supplement 29 · standard — Letter ↗AP
2019-04-09Labeling · Supplement 27 · standard — Letter ↗AP
2017-11-28Labeling · Supplement 26 · standard — Letter ↗AP
2017-02-24Labeling · Supplement 24 · standard — Letter ↗AP
2015-06-30Labeling · Supplement 22 · standard — Label ↗AP
2013-06-12Manufacturing (CMC) · Supplement 21 · standardAP
2012-09-19Labeling · Supplement 20 · standard — Label ↗AP
2012-04-23Labeling · Supplement 19 · standard — Label ↗AP
2012-04-05Labeling · Supplement 18 · standard — Label ↗AP
2011-10-31Labeling · Supplement 17 · standard — Letter ↗AP
2011-09-27Labeling · Supplement 16 · standard — Label ↗AP
2011-04-19Labeling · Supplement 13 · unknown — Label ↗AP
2011-01-26Labeling · Supplement 9 · standard — Label ↗AP
2010-12-01Labeling · Supplement 8 · unknown — Letter ↗AP
2010-09-15Labeling · Supplement 4 · unknown — Letter ↗AP
2010-04-01Manufacturing (CMC) · Supplement 3AP
2009-05-18Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
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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