Application 208030

Type
NDA
Sponsor
CHIESI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FERRIPROXDEFERIPRONESOLUTION;ORAL100MG/MLYesYes
002FERRIPROXDEFERIPRONESOLUTION;ORAL80MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10122-101FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-101FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
10122-101FERRIPROXdeferiproneChiesi USA, Inc.NDACurrent
52609-4502FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent
52609-4502FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent
52609-4502FERRIPROXdeferiproneApoPharma USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81762SUPPL 2025-03-28
81757SUPPL 2025-03-27
81756SUPPL 2025-03-27
69448SUPPL2021-12-01
69447SUPPL2021-12-01
69441SUPPL2021-12-01
67394SUPPL2021-05-04
67317SUPPL2021-05-03
67316SUPPL2021-05-03
61937SUPPL2020-02-21
61936SUPPL2020-02-21
61933SUPPL2020-02-21
53794SUPPL2018-04-23
53793SUPPL2018-04-23
53787SUPPL2018-04-23
47812ORIG2017-03-31
24531ORIG2016-06-09
23048ORIG2016-06-09
32879ORIG2015-09-10