FDA.reportPublic FDA data

Application 214770

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOXAFIL POWDERMIXPOSACONAZOLESUSPENSION, DELAYED RELEASE;ORALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-2224NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-2224NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-2224NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-2224NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-2224NOXAFILposaconazoleMerck Sharp & Dohme Corp.NDACurrent
0085-2224NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent
0085-2224NOXAFILposaconazoleMerck Sharp & Dohme LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84864SUPPL 2026-01-28
84858SUPPL 2026-01-28
80038SUPPL 2024-10-29
80027SUPPL 2024-10-28
69947SUPPL2022-01-21
69946SUPPL2022-01-21
69887SUPPL2022-01-18
69879SUPPL2022-01-14
69368ORIG2021-11-22
67671ORIG2021-06-03
67664ORIG2021-05-31