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FDA NDA · NDA020831

FORADIL

Sponsor: NOVARTIS

APPLICATION
NDA020831
TYPE
NDA
ORIGINAL APPROVAL
2001-02-16
LATEST ACTION
2016-03-02
ROUTE
INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

FORADIL · ReferenceDiscontinued
FORMOTEROL FUMARATE 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INHALATION

Approval history

2016-03-02Manufacturing (CMC) · Supplement 34 · standardAP
2013-12-13Manufacturing (CMC) · Supplement 33 · standardAP
2013-04-17Manufacturing (CMC) · Supplement 31 · standardAP
2013-03-29REMS · Supplement 32 — Letter ↗AP
2013-03-29Labeling · Supplement 29 · standard — Letter ↗AP
2013-02-08Manufacturing (CMC) · Supplement 30 · standardAP
2012-09-27Labeling · Supplement 28 · standard — Label ↗AP
2012-03-20Labeling · Supplement 27 · standard — Label ↗AP
2011-05-18REMS · Supplement 22 — Letter ↗AP
2011-05-03Labeling · Supplement 25 · standard — Letter ↗AP
2011-02-09Labeling · Supplement 24 · unknown — Letter ↗AP
2010-06-02Labeling · Supplement 21 · 901 required — Letter ↗AP
2006-06-19Labeling · Supplement 9 · standard — Label ↗AP
2003-06-27Efficacy · Supplement 5 · standard — Label ↗AP
2002-05-17Manufacturing (CMC) · Supplement 4 · standardAP
2001-11-21Manufacturing (CMC) · Supplement 3 · standardAP
2001-09-25Labeling · Supplement 2 · standard — Label ↗AP
2001-04-25Manufacturing (CMC) · Supplement 1 · standardAP
2001-02-16Type 1 - New Molecular Entity · Original · standard — 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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