FDA.reportPublic FDA data

Application 210867

Type
NDA
Sponsor
MDGH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIDECTINMOXIDECTINTABLET;ORAL2MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71705-050MoxidectinMoxidectinMedicines Development for Global HealthNDACurrent
71705-050MoxidectinMoxidectinMedicines Development Limited (trading as Medicines Development for Global Health)NDACurrent
71705-050MoxidectinMoxidectinMedicines Development for Global HealthNDACurrent
71705-051MoxidectinMoxidectinMedicines Development for Global HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81214SUPPL 2025-02-11
81179SUPPL 2025-02-10
66702SUPPL2021-03-09
66658SUPPL2021-03-09
57296SUPPL2019-01-22
57282SUPPL2019-01-22
54773ORIG2018-07-05
54547ORIG2018-06-14
54546ORIG2018-06-14