← FDA DRUG APPROVALS

FDA NDA · NDA022519

DUEXIS

Sponsor: HORIZON

APPLICATION
NDA022519
TYPE
NDA
ORIGINAL APPROVAL
2011-04-23
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DUEXIS · ReferenceDiscontinued
FAMOTIDINE 26.6MG, IBUPROFEN 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 14 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 13 · standard — Letter ↗AP
2019-07-22Labeling · Supplement 12 · standard — Label ↗AP
2017-06-07Labeling · Supplement 11 · standard — Label ↗AP
2016-07-08Manufacturing (CMC) · Supplement 10 · standardAP
2016-05-09Labeling · Supplement 9 · 901 order — Label ↗AP
2014-03-04Manufacturing (CMC) · Supplement 8 · standardAP
2013-10-31Labeling · Supplement 6 · unknownAP
2013-08-28Manufacturing (CMC) · Supplement 7 · standardAP
2013-08-13Manufacturing (CMC) · Supplement 4 · standardAP
2013-01-18Manufacturing (CMC) · Supplement 5 · standardAP
2011-04-23Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →