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FDA NDA · NDA209400

BERKLEY AND JENSEN OMEPRAZOLE

omeprazole

Sponsor: DEXCEL

APPLICATION
NDA209400
TYPE
NDA
ORIGINAL APPROVAL
2017-07-05
LATEST ACTION
2026-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

OMEPRAZOLE · ReferenceOver-the-counter
OMEPRAZOLE 20MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL

Approval history

2026-03-11Labeling · Supplement 21 · standard — Label ↗AP
2022-10-21Labeling · Supplement 12 · standard — Letter ↗AP
2021-07-07Labeling · Supplement 6 · standard — Letter ↗AP
2020-11-13Labeling · Supplement 10 · standard — Letter ↗AP
2020-04-29Labeling · Supplement 7 · standard — Letter ↗AP
2019-01-28Labeling · Supplement 5 · standard — Label ↗AP
2018-07-12Labeling · Supplement 3 · standard — Letter ↗AP
2018-06-12Labeling · Supplement 2 · standard — Letter ↗AP
2018-02-28Labeling · Supplement 1 · standard — Letter ↗AP
2017-07-05Type 3 - New Dosage Form · Original · standard — Letter ↗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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