Application 020829

Type: NDA
Sponsor: MSD MERCK CO

Related Records

Company: MSD MERCK CO

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	SINGULAIR	MONTELUKAST SODIUM	TABLET;ORAL	EQ 10MG BASE	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-9117	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-9117	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-9117	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-9117	SINGULAIR	montelukast sodium	Merck Sharp & Dohme Corp.	NDA	Current
21695-221	SINGULAIR	montelukast sodium	Rebel Distributors Corp	NDA	Current
68258-3033	SINGULAIR	montelukast sodium	Dispensing Solutions Inc.	NDA	Current
78206-172	SINGULAIR	montelukast sodium	Organon LLC	NDA	Current
78206-172	SINGULAIR	montelukast sodium	Organon LLC	NDA	Current

Documents

Document	Submission type	Date
68745	SUPPL	2021-09-24
66348	SUPPL	2021-02-24
66347	SUPPL	2021-02-24
66334	SUPPL	2021-02-23
62755	SUPPL	2020-04-30
62754	SUPPL	2020-04-30
62751	SUPPL	2020-04-30
59674	SUPPL	2019-08-12
59671	SUPPL	2019-08-12
57078	SUPPL	2018-12-31
57069	SUPPL	2018-12-30
57023	SUPPL	2018-12-26
57022	SUPPL	2018-12-26
46161	SUPPL	2016-12-15
46176	SUPPL	2016-12-14
35443	SUPPL	2014-12-19
25958	SUPPL	2014-11-28
25957	SUPPL	2013-12-31
13523	SUPPL	2013-12-31
13522	SUPPL	2013-03-26
25956	SUPPL	2013-03-22
13519	SUPPL	2012-10-22
3456	SUPPL	2012-10-22
25955	SUPPL	2012-10-02
13521	SUPPL	2012-09-28
13520	SUPPL	2012-07-18
25954	SUPPL	2012-07-17
25953	SUPPL	2012-03-28
35442	SUPPL	2012-03-26
41732	SUPPL	2012-02-14
3455	SUPPL	2011-12-21
13518	SUPPL	2011-12-20
25952	SUPPL	2011-06-17
3454	SUPPL	2011-05-03
13517	SUPPL	2011-04-29
35441	SUPPL	2010-08-19
3453	SUPPL	2010-08-16
25951	SUPPL	2010-04-29
13516	SUPPL	2010-04-28
3452	SUPPL	2009-11-10
13515	SUPPL	2009-09-15
13514	SUPPL	2009-02-04
25950	SUPPL	2009-01-30
23601	ORIG	2008-08-12
13512	SUPPL	2008-06-05
13513	SUPPL	2008-04-29
25949	SUPPL	2008-04-28
3451	SUPPL	2008-04-22
13511	SUPPL	2008-03-11
3450	SUPPL	2008-03-11
41730	SUPPL	2007-07-09
41731	SUPPL	2007-07-06
20987	SUPPL	2007-07-06
35438	SUPPL	2007-04-20
25948	SUPPL	2007-04-20
25947	SUPPL	2007-04-20
3449	SUPPL	2007-04-20
3445	SUPPL	2007-04-20
3448	SUPPL	2006-12-28
13510	SUPPL	2006-12-14
35440	SUPPL	2006-05-22
3447	SUPPL	2006-05-22
25945	SUPPL	2005-12-06
13508	SUPPL	2005-12-05
13507	SUPPL	2005-07-29
3444	SUPPL	2005-07-29
35439	SUPPL	2005-06-29
3446	SUPPL	2005-06-29
25946	SUPPL	2005-05-27
13509	SUPPL	2005-05-27
35437	SUPPL	2005-01-11
3443	SUPPL	2005-01-11
35436	SUPPL	2004-11-17
25944	SUPPL	2004-11-17
35435	SUPPL	2003-12-29
25943	SUPPL	2003-12-23
35434	SUPPL	2003-11-13
25942	SUPPL	2003-11-13
35433	SUPPL	2003-10-10
25941	SUPPL	2003-10-09
13505	SUPPL	2003-04-24
13506	SUPPL	2003-04-07
25940	SUPPL	2002-12-31
41729	SUPPL	2001-07-05
41728	ORIG	1998-02-20
35432	ORIG	1998-02-20
25939	ORIG	1998-02-20
53346	ORIG	1900-01-01
53345	ORIG	1900-01-01
53344	ORIG	1900-01-01