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FDA NDA · NDA022511

VIMOVO

Sponsor: HORIZON

APPLICATION
NDA022511
TYPE
NDA
ORIGINAL APPROVAL
2010-04-30
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

VIMOVO · ReferenceDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
VIMOVO · ReferenceDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-11-21Labeling · Supplement 30 · standard — Letter ↗AP
2023-07-18Labeling · Supplement 29 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 28 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 26 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 25 · standard — Letter ↗AP
2019-07-22Labeling · Supplement 24 · standard — Label ↗AP
2018-06-07Labeling · Supplement 23 · standard — Label ↗AP
2017-07-06Efficacy · Supplement 19 · standard — Label ↗AP
2016-10-24Labeling · Supplement 20 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 18 · standard — Letter ↗AP
2015-06-19Labeling · Supplement 16 · standard — Label ↗AP
2015-03-25Labeling · Supplement 15 · standard — Label ↗AP
2014-12-19Labeling · Supplement 17 · 901 required — Label ↗AP
2014-08-27Manufacturing (CMC) · Supplement 14 · standardAP
2014-05-14Manufacturing (CMC) · Supplement 13 · standardAP
2014-03-27Labeling · Supplement 10 · standard — Label ↗AP
2014-03-20Manufacturing (CMC) · Supplement 11 · standardAP
2014-02-25Labeling · Supplement 12 · 901 required — Label ↗AP
2013-06-12Manufacturing (CMC) · Supplement 9 · standardAP
2012-10-09Labeling · Supplement 8 · standard — Label ↗AP
2012-09-28Labeling · Supplement 7 · standard — Label ↗AP
2012-01-20Labeling · Supplement 6 · standard — Letter ↗AP
2011-11-18Labeling · Supplement 1 · unknown — Label ↗AP
2011-06-21Labeling · Supplement 2 · unknown — Label ↗AP
2011-06-21Labeling · Supplement 3 · unknown — Letter ↗AP
2011-05-20Labeling · Supplement 4 · 901 required — Label ↗AP
2010-04-30Type 4 - New Combination · Original · standard — Label ↗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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