FDA.reportPublic FDA data

Application 203565

Type
NDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INJECTAFERFERRIC CARBOXYMALTOSEINJECTABLE;INTRAVENOUS750MG IRON/15ML (50MG IRON/ML)YesYes
002INJECTAFERFERRIC CARBOXYMALTOSESOLUTION;INTRAVENOUS500MG IRON/10ML (50MG IRON/ML)YesYes
003INJECTAFERFERRIC CARBOXYMALTOSESOLUTION;INTRAVENOUS1GM IRON/20ML (50MG IRON/ML)YesYes
004INJECTAFERFERRIC CARBOXYMALTOSESOLUTION;INTRAVENOUS100MG IRON/2ML (50MG IRON/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0602InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0602InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0620InjectaferFerric CarboxymaltoseAmerican Regent, Inc.NDACurrent
0517-0620InjectaferFerric CarboxymaltoseAmerican Regent, Inc.NDACurrent
0517-0620InjectaferFerric CarboxymaltoseAmerican Regent, Inc.NDACurrent
0517-0620InjectaferFerric CarboxymaltoseAmerican Regent, Inc.NDACurrent
0517-0620InjectaferFerric CarboxymaltoseAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent
0517-0650InjectaferFerric Carboxymaltose InjectionAmerican Regent, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80815SUPPL 2025-01-06
80812SUPPL 2025-01-03
74423SUPPL 2023-06-01
74422SUPPL 2023-06-01
74419SUPPL 2023-06-01
74418SUPPL 2023-06-01
71604SUPPL2022-07-20
71603SUPPL2022-07-19
69388SUPPL2021-11-23
69363SUPPL2021-11-22
68542SUPPL2021-09-03
68294SUPPL2021-08-05
67385SUPPL2021-05-04
67278SUPPL2021-04-30
66313SUPPL2021-02-22
66205SUPPL2021-02-12
64575SUPPL2020-09-15
64572SUPPL2020-09-14
61920SUPPL2020-02-20
61919SUPPL2020-02-20
56171SUPPL2018-10-30
56114SUPPL2018-10-26
52120SUPPL2018-01-30
52118SUPPL2018-01-30
44886ORIG2013-09-04
22927ORIG2013-09-04
40312ORIG2013-07-30
10233ORIG2013-07-29