← FDA DRUG APPROVALS

FDA NDA · NDA202020

RAYOS

Sponsor: HORIZON

APPLICATION
NDA202020
TYPE
NDA
ORIGINAL APPROVAL
2012-07-26
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

RAYOS · ReferenceDiscontinued
PREDNISONE 2MG · TABLET, DELAYED RELEASE · ORAL
RAYOS · ReferenceDiscontinued
PREDNISONE 5MG · TABLET, DELAYED RELEASE · ORAL
RAYOS · ReferenceDiscontinued
PREDNISONE 1MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-06-05Labeling · Supplement 13 · standard — Label ↗AP
2019-12-27Labeling · Supplement 12 · standard — Letter ↗AP
2016-07-22Manufacturing (CMC) · Supplement 10 · standardAP
2016-02-05Manufacturing (CMC) · Supplement 9 · standardAP
2014-08-12Manufacturing (CMC) · Supplement 7 · standardAP
2014-05-12Manufacturing (CMC) · Supplement 5 · standardAP
2014-02-10Manufacturing (CMC) · Supplement 6 · standardAP
2013-10-25Manufacturing (CMC) · Supplement 4 · standardAP
2013-06-13Labeling · Supplement 3 · standard — Label ↗AP
2013-03-13Manufacturing (CMC) · Supplement 1 · standardAP
2012-07-26Type 3 - New Dosage Form · Original · standard — Summary Review ↗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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