← FDA DRUG APPROVALS

FDA NDA · NDA021409

SINGULAIR

montelukast sodium

Sponsor: ORGANON

APPLICATION
NDA021409
TYPE
NDA
ORIGINAL APPROVAL
2002-07-26
LATEST ACTION
2021-02-22
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued

Products

SINGULAIR · ReferenceDiscontinued
MONTELUKAST SODIUM EQ 4MG BASE/PACKET · GRANULE · ORAL

Approval history

2021-02-22Labeling · Supplement 52 · standard — Letter ↗AP
2020-04-29Labeling · Supplement 51 · standard — Letter ↗AP
2019-08-09Labeling · Supplement 50 · standard — Letter ↗AP
2018-12-21Labeling · Supplement 48 · standard — Label ↗AP
2018-12-21Labeling · Supplement 49 · standard — Label ↗AP
2016-12-13Labeling · Supplement 47 · standard — Letter ↗AP
2014-11-26Labeling · Supplement 45 · standard — Letter ↗AP
2013-12-30Labeling · Supplement 43 · standard — Letter ↗AP
2013-03-21Labeling · Supplement 42 · standard — Label ↗AP
2012-10-18Labeling · Supplement 39 · unknown — Letter ↗AP
2012-09-27Labeling · Supplement 40 · unknown — Letter ↗AP
2012-03-26Efficacy · Supplement 36 · standard — Letter ↗AP
2011-12-16Labeling · Supplement 37 · unknown — Letter ↗AP
2011-04-27Labeling · Supplement 34 · unknown — Label ↗AP
2010-08-10Labeling · Supplement 31 · unknown — Letter ↗AP
2010-04-26Labeling · Supplement 29 · standard — Label ↗AP
2009-08-19Labeling · Supplement 28 · standard — Label ↗AP
2009-01-27Labeling · Supplement 27 · standard — Label ↗AP
2008-04-24Labeling · Supplement 26 · standard — Letter ↗AP
2008-04-21Labeling · Supplement 25 · standard — Label ↗AP
2008-03-07Labeling · Supplement 23 · standard — Letter ↗AP
2007-04-13Efficacy · Supplement 16 · unknown — Label ↗AP
2006-12-08Labeling · Supplement 19 · standard — Label ↗AP
2006-05-19Labeling · Supplement 18 · standard — Label ↗AP
2005-11-30Efficacy · Supplement 14 · unknown — Letter ↗AP
2005-07-27Efficacy · Supplement 12 · unknown — Letter ↗AP
2005-06-27Labeling · Supplement 17 · standard — Label ↗AP
2005-05-26Labeling · Supplement 15 · standard — Label ↗AP
2004-12-29Labeling · Supplement 11 · standardAP
2004-11-15Labeling · Supplement 10 · standard — Letter ↗AP
2003-12-19Labeling · Supplement 7 · standard — Letter ↗AP
2003-10-02Labeling · Supplement 5 · standard — Letter ↗AP
2002-12-31Efficacy · Supplement 3 · unknown — Letter ↗AP
2002-07-26Type 3 - New Dosage Form · Original · standard — Letter ↗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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