FDA.reportPublic FDA data

Application 205641

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASMANEX HFAMOMETASONE FUROATEAEROSOL, METERED;INHALATION0.10MG/INHYesNo
002ASMANEX HFAMOMETASONE FUROATEAEROSOL, METERED;INHALATION0.20MG/INHYesYes
003ASMANEX HFAMOMETASONE FUROATEAEROSOL, METERED;INHALATION0.05MG/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-2222ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-2222ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-2222ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-2222ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4333ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4333ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4333ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4333ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4333ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4333ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4334ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4334ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4334ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4334ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4334ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
0085-4334ASMANEX HFAMOMETASONE FUROATEMerck Sharp & Dohme Corp.NDACurrent
78206-111ASMANEX HFAMOMETASONE FUROATEOrganon LLCNDACurrent
78206-111ASMANEX HFAMOMETASONE FUROATEOrganon LLCNDACurrent
78206-112ASMANEX HFAMOMETASONE FUROATEOrganon LLCNDACurrent
78206-112ASMANEX HFAMOMETASONE FUROATEOrganon LLCNDACurrent
78206-113ASMANEX HFAMOMETASONE FUROATEOrganon LLCNDACurrent
78206-113ASMANEX HFAMOMETASONE FUROATEOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59693SUPPL2019-08-13
59686SUPPL2019-08-13
53516SUPPL2018-03-29
53515SUPPL2018-03-29
53461SUPPL2018-03-27
53460SUPPL2018-03-27
40490SUPPL2016-07-13
10485SUPPL2016-07-13
40489SUPPL2015-08-04
40488SUPPL2015-07-10
32698SUPPL2015-06-18
44929ORIG2014-11-03
43497ORIG2014-11-03
19671ORIG2014-05-12
10484ORIG2014-05-01
63178ORIG1900-01-01
51383SUPPL1900-01-01
51382ORIG1900-01-01
51381ORIG1900-01-01
51380ORIG1900-01-01