FDA.reportPublic FDA data

Application 021067

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASMANEX TWISTHALERMOMETASONE FUROATEPOWDER;INHALATION0.22MG/INHYesYes
002ASMANEX TWISTHALERMOMETASONE FUROATEPOWDER;INHALATION0.11MG/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1341ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1341ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1341ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1341ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1341ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1461ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1461ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1461ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1461ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
0085-1461ASMANEXMometasone FuroateMerck Sharp & Dohme Corp.NDACurrent
78206-114ASMANEXMometasone FuroateOrganon LLCNDACurrent
78206-114ASMANEXMometasone FuroateOrganon LLCNDACurrent
78206-114ASMANEXMometasone FuroateOrganon LLCNDACurrent
78206-115ASMANEXMometasone FuroateOrganon LLCNDACurrent
78206-115ASMANEXMometasone FuroateOrganon LLCNDACurrent
78206-115ASMANEXMometasone FuroateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66275SUPPL2021-02-18
66251SUPPL2021-02-17
61429SUPPL2019-12-23
61382SUPPL2019-12-23
53512SUPPL2018-03-29
53511SUPPL2018-03-29
53459SUPPL2018-03-27
53458SUPPL2018-03-27
26619SUPPL2010-09-21
14272SUPPL2010-09-20
26618SUPPL2010-09-02
14271SUPPL2010-09-02
4188SUPPL2008-02-29
41919ORIG2006-07-05
35997ORIG2005-03-31
26617ORIG2005-03-31
53338ORIG1900-01-01
53337ORIG1900-01-01
53336ORIG1900-01-01
53335ORIG1900-01-01