FDA.reportPublic FDA data

Application 205596

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOXAFILPOSACONAZOLESOLUTION;INTRAVENOUS300MG/16.7ML (18MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4331NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84863SUPPL 2026-01-28
84857SUPPL 2026-01-28
80037SUPPL 2024-10-29
80026SUPPL 2024-10-28
69943SUPPL2022-01-21
69942SUPPL2022-01-21
69886SUPPL2022-01-18
69878SUPPL2022-01-14
67859SUPPL2021-06-22
67855SUPPL2021-06-22
67674SUPPL2021-06-03
67666SUPPL2021-06-02
64611SUPPL2020-09-18
64595SUPPL2020-09-17
57975SUPPL2019-03-12
57972SUPPL2019-03-12
57795SUPPL2019-02-22
57772SUPPL2019-02-22
51009SUPPL2018-01-09
50985SUPPL2018-01-08
46968SUPPL2017-01-24
45297SUPPL2016-09-15
19665SUPPL2015-11-19
19664SUPPL2015-11-19
32693SUPPL2015-11-18
10472SUPPL2015-11-18
44925ORIG2014-10-10
22996ORIG2014-10-10
19663ORIG2014-03-19
10471ORIG2014-03-14