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FDA NDA · NDA020845

INOMAX

nitric oxide

Sponsor: MALLINCKRODT IRELAND

APPLICATION
NDA020845
TYPE
NDA
ORIGINAL APPROVAL
1999-12-23
LATEST ACTION
2023-01-17
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
GAS
MARKETING STATUS
Prescription, Discontinued

Products

INOMAX · ReferencePrescription
NITRIC OXIDE 800PPM · GAS · INHALATION
INOMAX · ReferencePrescription
NITRIC OXIDE 4880PPM · GAS · INHALATION
INOMAX · ReferenceDiscontinued
NITRIC OXIDE 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GAS · INHALATION

Approval history

2023-01-17Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2019-02-13Labeling · Supplement 20 · standard — Label ↗AP
2016-04-05Labeling · Supplement 18 · standard — Letter ↗AP
2015-10-09Labeling · Supplement 16 · standard — Label ↗AP
2015-10-09Efficacy · Supplement 17 · standard — Label ↗AP
2014-02-28Manufacturing (CMC) · Supplement 15 · priorityAP
2013-03-04Labeling · Supplement 14 · unknown — Label ↗AP
2010-12-21Efficacy · Supplement 11 · priority — Label ↗AP
2009-08-26Labeling · Supplement 9 · standard — Label ↗AP
2007-12-04Labeling · Supplement 4 · standard — Letter ↗AP
2004-06-15Labeling · Supplement 2 · standard — Letter ↗AP
2001-05-21Labeling · Supplement 1 · standardAP
1999-12-23Type 1 - New Molecular Entity · Original · priority — Pediatric Medical 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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