FDA.reportPublic FDA data

Application 211225

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYKADIACERITINIBTABLET;ORAL150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0694ZYKADIAceritinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0694ZYKADIAceritinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0694ZYKADIAceritinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0694ZYKADIAceritinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0694ZYKADIAceritinibNovartis Pharmaceuticals CorporationNDACurrent
0078-0694ZYKADIAceritinibNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68977SUPPL2021-10-13
68955SUPPL2021-10-12
68448SUPPL2021-08-24
68431SUPPL2021-08-22
58439ORIG2019-04-26
58040ORIG2019-03-19
58033ORIG2019-03-19