FDA.reportPublic FDA data

Application 021409

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SINGULAIRMONTELUKAST SODIUMGRANULE;ORALEQ 4MG BASE/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3841SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3841SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3841SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3841SINGULAIRmontelukast sodiumMerck Sharp & Dohme Corp.NDACurrent
66993-416Montelukast Sodiummontelukast sodiumPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-416Montelukast Sodiummontelukast sodiumPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
78206-171SINGULAIRmontelukast sodiumOrganon LLCNDACurrent
78206-171SINGULAIRmontelukast sodiumOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66352SUPPL2021-02-24
66351SUPPL2021-02-24
66336SUPPL2021-02-23
62759SUPPL2020-04-30
62758SUPPL2020-04-30
62753SUPPL2020-04-30
59676SUPPL2019-08-12
59673SUPPL2019-08-12
57082SUPPL2018-12-31
57081SUPPL2018-12-31
57027SUPPL2018-12-26
57026SUPPL2018-12-26
46172SUPPL2016-12-15
46163SUPPL2016-12-15
15388SUPPL2014-12-19
5276SUPPL2014-11-28
15387SUPPL2013-12-31
5275SUPPL2013-12-31
36840SUPPL2013-03-26
27692SUPPL2013-03-22
36839SUPPL2012-10-22
27691SUPPL2012-10-22
5274SUPPL2012-10-02
15386SUPPL2012-09-28
5272SUPPL2012-03-28
15384SUPPL2012-03-26
5273SUPPL2011-12-21
15385SUPPL2011-12-20
27690SUPPL2011-05-03
36838SUPPL2011-04-29
15383SUPPL2010-08-19
5271SUPPL2010-08-16
5270SUPPL2010-04-29
36837SUPPL2010-04-28
27689SUPPL2009-11-10
36836SUPPL2009-08-28
36835SUPPL2009-02-04
27688SUPPL2009-01-30
23654ORIG2008-08-12
36833SUPPL2008-06-05
36834SUPPL2008-04-29
5269SUPPL2008-04-28
5268SUPPL2008-04-22
15382SUPPL2008-03-13
5267SUPPL2008-03-11
21640SUPPL2007-07-09
21641SUPPL2007-07-06
36830SUPPL2007-04-20
27684SUPPL2007-04-20
27687SUPPL2006-12-28
15381SUPPL2006-12-14
36832SUPPL2006-05-22
27686SUPPL2006-05-22
27682SUPPL2005-12-06
36828SUPPL2005-12-05
36827SUPPL2005-07-29
5266SUPPL2005-07-29
36831SUPPL2005-06-29
27685SUPPL2005-06-29
36829SUPPL2005-05-27
27683SUPPL2005-05-27
21639ORIG2004-11-22
36826SUPPL2004-11-17
27681SUPPL2004-11-17
36825SUPPL2004-06-17
15380SUPPL2003-12-29
5265SUPPL2003-12-23
5264SUPPL2003-10-09
15379SUPPL2003-04-09
5263SUPPL2003-01-23
15378ORIG2002-07-26
5262ORIG2002-07-26