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FDA NDA · NDA208025

EQUATE LANSOPRAZOLE

lansoprazole

Sponsor: DEXCEL

APPLICATION
NDA208025
TYPE
NDA
ORIGINAL APPROVAL
2016-06-07
LATEST ACTION
2026-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

LANSOPRAZOLEOver-the-counter
LANSOPRAZOLE 15MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL

Approval history

2026-03-11Labeling · Supplement 18 · standard — Label ↗AP
2022-11-01Labeling · Supplement 12 · standard — Letter ↗AP
2020-11-20Labeling · Supplement 10 · standard — Letter ↗AP
2019-04-09Labeling · Supplement 8 · standard — Letter ↗AP
2017-11-30Manufacturing (CMC) · Supplement 6 — Label ↗AP
2017-11-30Labeling · Supplement 7 · standard — Letter ↗AP
2017-11-15Labeling · Supplement 5 · standard — Letter ↗AP
2017-05-09Labeling · Supplement 3 · standard — Letter ↗AP
2017-01-25Labeling · Supplement 1 · standard — Letter ↗AP
2016-06-07Type 5 - New Formulation or New Manufacturer · 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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