FDA.report

Application 022003

Type
NDA
Sponsor
SCHERING

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NOXAFILPOSACONAZOLESUSPENSION;ORAL40MG/MLYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-1328NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent

Documents

DocumentSubmission typeDate
84861SUPPL 2026-01-28
84855SUPPL 2026-01-27
80035SUPPL 2024-10-29
80024SUPPL 2024-10-28
70229SUPPL2022-02-23
69939SUPPL2022-01-21
69938SUPPL2022-01-21
69884SUPPL2022-01-18
69876SUPPL2022-01-14
69807SUPPL2022-01-04
64612SUPPL2020-09-18
64593SUPPL2020-09-17
57973SUPPL2019-03-12
57970SUPPL2019-03-12
57793SUPPL2019-02-22
57770SUPPL2019-02-22
51007SUPPL2018-01-09
50983SUPPL2018-01-08
46970SUPPL2017-01-24
45295SUPPL2016-09-15
38064SUPPL2015-11-19
16744SUPPL2015-11-19
29048SUPPL2015-11-18
29047SUPPL2015-11-18
16743SUPPL2015-07-22
29046SUPPL2015-07-16
6658SUPPL2012-06-25
6657SUPPL2012-06-25
38063SUPPL2012-06-22
16742SUPPL2012-06-22
29045SUPPL2010-09-13
16741SUPPL2010-09-10
29044SUPPL2009-02-23
38062SUPPL2009-02-20
29043SUPPL2008-05-21
6656SUPPL2008-05-21
42384ORIG2006-11-09
29042ORIG2006-09-20
38061ORIG2006-09-18
51542ORIG1900-01-01
51541ORIG1900-01-01