FDA.reportPublic FDA data

Application 205053

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOXAFILPOSACONAZOLETABLET, DELAYED RELEASE;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-4324NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0254-2045POSACONAZOLEposaconazolePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-2045POSACONAZOLEposaconazolePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-2045POSACONAZOLEposaconazolePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-2045POSACONAZOLEposaconazolePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-2045POSACONAZOLEposaconazolePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-2045POSACONAZOLEposaconazolePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-2045POSACONAZOLEposaconazolePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
63629-2236POSACONAZOLEposaconazoleBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2236POSACONAZOLEposaconazoleBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2236POSACONAZOLEposaconazoleBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2236POSACONAZOLEposaconazoleBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2236POSACONAZOLEposaconazoleBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84862SUPPL 2026-01-28
84856SUPPL 2026-01-28
80036SUPPL 2024-10-29
80025SUPPL 2024-10-28
69941SUPPL2022-01-21
69940SUPPL2022-01-21
69885SUPPL2022-01-18
69877SUPPL2022-01-14
67879SUPPL2021-06-23
67858SUPPL2021-06-22
67673SUPPL2021-06-03
67665SUPPL2021-06-02
64610SUPPL2020-09-18
64594SUPPL2020-09-17
57974SUPPL2019-03-12
57971SUPPL2019-03-12
57794SUPPL2019-02-22
57771SUPPL2019-02-22
51008SUPPL2018-01-09
50984SUPPL2018-01-08
46969SUPPL2017-01-24
45296SUPPL2016-09-15
40439SUPPL2015-11-19
40438SUPPL2015-11-19
32622SUPPL2015-11-18
32621SUPPL2015-11-18
40437SUPPL2015-08-19
44912ORIG2015-03-16
22972ORIG2015-03-16
32620SUPPL2014-06-12
32619ORIG2013-11-27
40436ORIG2013-11-26
51588ORIG1900-01-01
51586ORIG1900-01-01
51584ORIG1900-01-01