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FDA NDA · NDA022032

GOOD NEIGHBOR PHARMACY OMEPRAZOLE

omeprazole

Sponsor: DEXCEL PHARMA

APPLICATION
NDA022032
TYPE
NDA
ORIGINAL APPROVAL
2007-12-04
LATEST ACTION
2025-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

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

Approval history

2025-10-03Manufacturing (CMC) · Supplement 70 — Letter ↗AP
2024-11-08Manufacturing (CMC) · Supplement 65 — Letter ↗AP
2022-09-30Labeling · Supplement 57 · standard — Letter ↗AP
2021-10-21Manufacturing (CMC) · Supplement 52 — Letter ↗AP
2021-07-07Labeling · Supplement 46 · standard — Letter ↗AP
2019-04-08Labeling · Supplement 41 · standard — Label ↗AP
2017-11-13Labeling · Supplement 38 · standard — Label ↗AP
2017-10-30Labeling · Supplement 37 · standard — Letter ↗AP
2016-12-01Manufacturing (CMC) · Supplement 34 · standardAP
2016-02-10Labeling · Supplement 32 · standard — Label ↗AP
2016-02-08Manufacturing (CMC) · Supplement 31 · standardAP
2016-01-05Manufacturing (CMC) · Supplement 25 · standardAP
2015-08-07Manufacturing (CMC) · Supplement 26 · standardAP
2015-06-11Labeling · Supplement 29 · standard — Letter ↗AP
2015-06-01Manufacturing (CMC) · Supplement 28 · standardAP
2015-03-30Manufacturing (CMC) · Supplement 27 · standardAP
2015-03-06Manufacturing (CMC) · Supplement 24 · standard — Review ↗AP
2013-09-13Manufacturing (CMC) · Supplement 22 · standardAP
2013-08-16Labeling · Supplement 21 · standard — Label ↗AP
2012-10-29Labeling · Supplement 20 · standard — Letter ↗AP
2012-09-10Labeling · Supplement 19 · standard — Letter ↗AP
2012-04-09Labeling · Supplement 16 · standard — Letter ↗AP
2011-06-27Labeling · Supplement 12 · unknown — Letter ↗AP
2010-07-16Labeling · Supplement 8 · standard — Letter ↗AP
2009-09-21Manufacturing (CMC) · Supplement 4AP
2009-04-02Labeling · Supplement 3 · standard — Letter ↗AP
2007-12-04Type 5 - New Formulation or New Manufacturer · Original · standard — Summary 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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