FDA.reportPublic FDA data

Application 022518

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DULERAFORMOTEROL FUMARATE; MOMETASONE FUROATEAEROSOL, METERED;INHALATION0.005MG/INH;0.1MG/INHYesYes
002DULERAFORMOTEROL FUMARATE; MOMETASONE FUROATEAEROSOL, METERED;INHALATION0.005MG/INH;0.2MG/INHYesYes
003DULERAFORMOTEROL FUMARATE; MOMETASONE FUROATEAEROSOL, METERED;INHALATION0.005MG/INH;0.05MG/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-2223Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-2223Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-2223Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-2223Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-4610Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-4610Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-4610Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-4610Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-4610Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-4610Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-7206Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-7206Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-7206Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-7206Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-7206Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
0085-7206Duleramometasone furoate and formoterol fumarate dihydrateMerck Sharp & Dohme Corp.NDACurrent
50090-1916Duleramometasone furoate and formoterol fumarate dihydrateA-S Medication SolutionsNDACurrent
78206-125Duleramometasone furoate and formoterol fumarate dihydrateOrganon LLCNDACurrent
78206-125Duleramometasone furoate and formoterol fumarate dihydrateOrganon LLCNDACurrent
78206-126Duleramometasone furoate and formoterol fumarate dihydrateOrganon LLCNDACurrent
78206-126Duleramometasone furoate and formoterol fumarate dihydrateOrganon LLCNDACurrent
78206-127Duleramometasone furoate and formoterol fumarate dihydrateOrganon LLCNDACurrent
78206-127Duleramometasone furoate and formoterol fumarate dihydrateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85777SUPPL 2026-04-28
82642SUPPL 2025-06-24
59685SUPPL2019-08-13
59684SUPPL2019-08-13
53514SUPPL2018-03-29
53513SUPPL2018-03-29
53468SUPPL2018-03-27
53467SUPPL2018-03-27
50927SUPPL2017-12-27
50837SUPPL2017-12-22
48867SUPPL2017-06-29
48848SUPPL2017-06-28
29821SUPPL2016-07-13
17673SUPPL2016-07-13
7494SUPPL2015-12-29
38805SUPPL2015-04-24
29820SUPPL2014-04-18
29819SUPPL2013-08-22
17672SUPPL2013-08-22
17671SUPPL2013-08-09
7493SUPPL2013-08-01
38804SUPPL2013-01-22
7492SUPPL2013-01-17
29818SUPPL2012-11-29
29817SUPPL2012-11-29
17670SUPPL2012-11-28
7491SUPPL2012-11-26
29816SUPPL2012-08-23
17669SUPPL2012-08-22
38803SUPPL2011-08-24
38802SUPPL2011-08-24
29815SUPPL2011-08-22
7490SUPPL2011-08-22
42546ORIG2011-05-25
24329ORIG2011-05-25
7489ORIG2010-06-29
38801ORIG2010-06-24
64021ORIG1900-01-01
54119ORIG1900-01-01
54118ORIG1900-01-01
54117ORIG1900-01-01
52903ORIG1900-01-01
51384SUPPL1900-01-01