FDA.report

Application 020830

Type
NDA
Sponsor
MSD MERCK CO

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SINGULAIRMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 5MG BASEYesYes
002SINGULAIRMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 4MG BASEYesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-1711SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-1711SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-1711SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-1711SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-9275SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-9275SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-9275SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-9275SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
21695-565SINGULAIRmontelukast sodiumRebel Distributors CorpNDACurrent
63629-2979SINGULAIRmontelukast sodiumBryant Ranch PrepackNDACurrent
63629-3701SINGULAIRmontelukast sodiumBryant Ranch PrepackNDACurrent
68258-3032SINGULAIRmontelukast sodiumDispensing Solutions Inc.NDACurrent
78206-170SINGULAIRmontelukast sodiumOrganon LLCNDACurrent
78206-170SINGULAIRmontelukast sodiumOrganon LLCNDACurrent
78206-173SINGULAIRmontelukast sodiumOrganon LLCNDACurrent
78206-173SINGULAIRmontelukast sodiumOrganon LLCNDACurrent

Documents

DocumentSubmission typeDate
66350SUPPL2021-02-24
66349SUPPL2021-02-24
66335SUPPL2021-02-23
62757SUPPL2020-04-30
62756SUPPL2020-04-30
62752SUPPL2020-04-30
59675SUPPL2019-08-12
59672SUPPL2019-08-12
57080SUPPL2018-12-31
57079SUPPL2018-12-31
57025SUPPL2018-12-26
57024SUPPL2018-12-26
46162SUPPL2016-12-15
46177SUPPL2016-12-14
13541SUPPL2014-12-19
3475SUPPL2014-11-28
35455SUPPL2013-12-31
3474SUPPL2013-12-31
13540SUPPL2013-03-26
25973SUPPL2013-03-22
13538SUPPL2012-10-22
3472SUPPL2012-10-22
3473SUPPL2012-10-02
13539SUPPL2012-09-28
25971SUPPL2012-03-28
13536SUPPL2012-03-27
25972SUPPL2011-12-21
13537SUPPL2011-12-20
25970SUPPL2011-06-17
3471SUPPL2011-05-03
35454SUPPL2011-04-29
13535SUPPL2010-08-19
3470SUPPL2010-08-16
25969SUPPL2010-04-29
35453SUPPL2010-04-28
25968SUPPL2009-11-10
35452SUPPL2009-08-28
35451SUPPL2009-02-04
25967SUPPL2009-01-30
23602ORIG2008-08-12
13534SUPPL2008-06-05
35450SUPPL2008-04-29
3469SUPPL2008-04-28
3468SUPPL2008-04-22
35449SUPPL2008-03-13
3467SUPPL2008-03-11
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35448SUPPL2006-12-14
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13529SUPPL2005-07-29
3462SUPPL2005-07-29
25963SUPPL2005-06-29
13532SUPPL2005-06-29
35447SUPPL2005-05-27
3464SUPPL2005-05-27
3457ORIG2005-04-26
35446SUPPL2005-01-11
25962SUPPL2005-01-11
13528SUPPL2004-11-17
3461SUPPL2004-11-17
35444SUPPL2004-06-17
13526SUPPL2004-06-17
35445SUPPL2003-12-29
3460SUPPL2003-12-23
25961SUPPL2003-11-13
13527SUPPL2003-11-13
25960SUPPL2003-10-09
13525SUPPL2003-04-24
3459SUPPL2002-12-31
3458SUPPL2001-11-23
20989SUPPL2001-09-07
41733SUPPL2001-07-05
20988ORIG2001-05-24
25959SUPPL2000-03-03
13524SUPPL2000-03-03