Application 021825

Type
NDA
Sponsor
CHIESI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FERRIPROXDEFERIPRONETABLET;ORAL500MGYesYes
002FERRIPROXDEFERIPRONETABLET;ORAL1GMYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10122-100FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-100FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-100FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-100FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-103FERRIPROXDEFERIPRONEChiesi USA, Inc.NDACurrent
10122-103FERRIPROXDEFERIPRONEChiesi USA, Inc.NDACurrent
10122-103FERRIPROXDEFERIPRONEChiesi USA, Inc.NDACurrent
10122-103FERRIPROXDEFERIPRONEChiesi USA, Inc.NDACurrent
52609-0006FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent
52609-0006FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent
52609-0006FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent
52609-0007FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent
52609-0007FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent
52609-0007FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81761SUPPL 2025-03-28
81759SUPPL 2025-03-27
81758SUPPL 2025-03-27
69444SUPPL2021-12-01
69443SUPPL2021-12-01
69440SUPPL2021-11-30
67390SUPPL2021-05-04
67313SUPPL2021-05-03
67312SUPPL2021-05-03
61935SUPPL2020-02-21
61934SUPPL2020-02-21
61929SUPPL2020-02-21
59502SUPPL2019-07-30
59501SUPPL2019-07-30
59463SUPPL2019-07-26
37728SUPPL2015-03-02
6273SUPPL2015-02-26
37727SUPPL2012-04-24
6272SUPPL2012-04-24
44652ORIG2011-12-02
21835ORIG2011-11-30
37726ORIG2011-10-14
28667ORIG2011-10-14