FDA.reportPublic FDA data

Application 212269

Type
NDA
Sponsor
APOPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FERRIPROXDEFERIPRONETABLET;ORAL1000MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10122-104FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-104FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-104FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-104FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-104FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81765SUPPL 2025-03-28
81754SUPPL 2025-03-27
81753SUPPL 2025-03-27
69446SUPPL2021-12-01
69445SUPPL2021-12-01
69442SUPPL2021-12-01
67395SUPPL2021-05-04
67315SUPPL2021-05-03
67314SUPPL2021-05-03
65391ORIG2020-11-30
63167ORIG2020-05-20
63166ORIG2020-05-20
63165ORIG2020-05-20