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FDA NDA · NDA020762

NASONEX

Sponsor: ORGANON LLC

APPLICATION
NDA020762
TYPE
NDA
ORIGINAL APPROVAL
1997-10-01
LATEST ACTION
2022-06-28
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

NASONEX · ReferenceDiscontinued
MOMETASONE FUROATE 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2022-06-28Labeling · Supplement 56 · standard — Letter ↗AP
2020-09-09Labeling · Supplement 55 · standard — Letter ↗AP
2018-06-22Labeling · Supplement 53 · standard — Letter ↗AP
2018-06-22Labeling · Supplement 52 · standard — Letter ↗AP
2015-03-03Manufacturing (CMC) · Supplement 51 · standard — Review ↗AP
2014-10-27Manufacturing (CMC) · Supplement 50 · standard — Review ↗AP
2014-04-18Manufacturing (CMC) · Supplement 49 · standard — Review ↗AP
2012-11-16Manufacturing (CMC) · Supplement 48 · standardAP
2011-01-19Efficacy · Supplement 44 · standard — Label ↗AP
2010-05-26Efficacy · Supplement 38 · standard — Label ↗AP
2004-12-15Efficacy · Supplement 23 · unknown — Review ↗AP
2004-08-25Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
2003-12-18Labeling · Supplement 21 · standard — Label ↗AP
2003-03-03Labeling · Supplement 14 · standard — Review ↗AP
2002-09-13Manufacturing (CMC) · Supplement 13 · standardAP
2002-07-17Efficacy · Supplement 11 · standard — Label ↗AP
2002-01-11Manufacturing (CMC) · Supplement 12 · standardAP
2001-02-22Manufacturing (CMC) · Supplement 10 · standardAP
2000-12-01Labeling · Supplement 9 · standardAP
2000-10-04Manufacturing (CMC) · Supplement 8 · standardAP
1999-12-02Efficacy · Supplement 4 · standardAP
1999-04-16Manufacturing (CMC) · Supplement 6 · standardAP
1998-11-18Efficacy · Supplement 1 · standard — Review ↗AP
1998-11-02Manufacturing (CMC) · Supplement 3 · standardAP
1998-06-11Manufacturing (CMC) · Supplement 2 · standardAP
1997-10-01Type 3 - New Dosage Form · 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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