← FDA DRUG APPROVALS

FDA NDA · NDA020830

SINGULAIR

montelukast sodium

Sponsor: ORGANON

APPLICATION
NDA020830
TYPE
NDA
ORIGINAL APPROVAL
1998-02-20
LATEST ACTION
2021-02-22
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription, Discontinued

Products

SINGULAIR · ReferencePrescription
MONTELUKAST SODIUM EQ 5MG BASE · TABLET, CHEWABLE · ORAL
SINGULAIR · ReferenceDiscontinued
MONTELUKAST SODIUM EQ 4MG BASE · TABLET, CHEWABLE · ORAL

Approval history

2021-02-22Labeling · Supplement 76 · standard — Letter ↗AP
2020-04-29Labeling · Supplement 75 · standard — Letter ↗AP
2019-08-09Labeling · Supplement 74 · standard — Letter ↗AP
2018-12-21Labeling · Supplement 72 · standard — Label ↗AP
2018-12-21Labeling · Supplement 73 · standard — Label ↗AP
2016-12-13Labeling · Supplement 71 · standard — Letter ↗AP
2014-11-26Labeling · Supplement 70 · standard — Letter ↗AP
2014-10-29Manufacturing (CMC) · Supplement 67 · standardAP
2013-12-30Labeling · Supplement 68 · standard — Letter ↗AP
2013-03-21Labeling · Supplement 66 · standard — Label ↗AP
2012-10-18Labeling · Supplement 63 · unknown — Label ↗AP
2012-09-27Labeling · Supplement 64 · unknown — Letter ↗AP
2012-03-26Efficacy · Supplement 61 · standard — Label ↗AP
2011-12-16Labeling · Supplement 62 · unknown — Label ↗AP
2011-06-10Labeling · Supplement 55 · unknown — Letter ↗AP
2011-04-27Labeling · Supplement 59 · unknown — Letter ↗AP
2010-08-10Labeling · Supplement 56 · unknown — Letter ↗AP
2010-04-26Labeling · Supplement 53 · standard — Letter ↗AP
2009-08-19Labeling · Supplement 52 · standard — Letter ↗AP
2009-01-27Labeling · Supplement 51 · standard — Letter ↗AP
2008-04-24Labeling · Supplement 50 · standard — Letter ↗AP
2008-04-21Labeling · Supplement 49 · standard — Label ↗AP
2008-03-07Labeling · Supplement 48 · standard — Letter ↗AP
2007-12-07Labeling · Supplement 47 · standard — Letter ↗AP
2007-04-13Labeling · Supplement 43 · standard — Letter ↗AP
2007-04-13Efficacy · Supplement 38 · unknown — Label ↗AP
2006-12-08Labeling · Supplement 41 · standard — Letter ↗AP
2006-05-19Labeling · Supplement 40 · standard — Label ↗AP
2005-11-30Efficacy · Supplement 36 · standard — Label ↗AP
2005-07-27Efficacy · Supplement 35 · unknown — Label ↗AP
2005-06-27Labeling · Supplement 39 · standard — Label ↗AP
2005-05-26Labeling · Supplement 37 · standard — Letter ↗AP
2004-12-29Labeling · Supplement 34 · standard — Letter ↗AP
2004-11-15Labeling · Supplement 33 · standard — Label ↗AP
2003-12-19Labeling · Supplement 29 · standard — Review ↗AP
2003-11-05Labeling · Supplement 28 · standard — Review ↗AP
2003-10-02Labeling · Supplement 26 · standard — Review ↗AP
2002-12-31Efficacy · Supplement 20 · standard — Letter ↗AP
2002-10-07Manufacturing (CMC) · Supplement 21 · standardAP
2002-02-11Manufacturing (CMC) · Supplement 19 · standardAP
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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