FDA.reportPublic FDA data

Application 021135

Type
NDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENOFERIRON SUCROSEINJECTABLE;INTRAVENOUSEQ 100MG BASE/5ML (EQ 20MG BASE/ML)YesYes
002VENOFERIRON SUCROSEINJECTABLE;INTRAVENOUSEQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)YesNo
003VENOFERIRON SUCROSEINJECTABLE;INTRAVENOUSEQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)NoNo
004VENOFERIRON SUCROSEINJECTABLE;INTRAVENOUSEQ 200MG BASE/10ML (EQ 20MG BASE/ML)YesNo
005VENOFERIRON SUCROSEINJECTABLE;INTRAVENOUSEQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2310Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2325Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
0517-2340Venoferiron sucroseAmerican Regent, Inc.NDACurrent
49230-530Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-530Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-530Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-530Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-530Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-530Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-530Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-534Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-534Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-534Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-534Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-534Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-534Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
49230-534Venoferiron sucroseFresenius Medical Care Holdings, Inc.NDACurrent
50090-4541Venoferiron sucroseA-S Medication SolutionsNDACurrent
50090-4541Venoferiron sucroseA-S Medication SolutionsNDACurrent
51662-1568VENOFER (IRON SUCROSE)VENOFER (IRON SUCROSE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85381SUPPL 2026-03-16
85380SUPPL 2026-03-16
79298SUPPL 2024-08-02
79289SUPPL 2024-08-02
66971SUPPL2021-04-01
65945SUPPL2021-01-21
64592SUPPL2020-09-17
64569SUPPL2020-09-14
56945SUPPL2018-12-21
56891SUPPL2018-12-20
50554SUPPL2017-12-01
50525SUPPL2017-11-29
14478SUPPL2013-04-01
14479SUPPL2012-09-25
26880SUPPL2012-09-24
14477SUPPL2011-06-29
26879SUPPL2011-06-28
41974SUPPL2008-07-30
26878SUPPL2008-01-09
36199SUPPL2007-12-14
14476SUPPL2007-02-21
36198SUPPL2005-10-19
4438SUPPL2005-10-19
26876SUPPL2005-06-21
14475SUPPL2005-06-21
26877SUPPL2005-03-31
36197ORIG2004-06-29
21469ORIG2004-06-29
26875SUPPL2003-07-24
14474SUPPL2003-06-08
4437SUPPL2003-06-08
4436ORIG2000-11-13
51212SUPPL1900-01-01
51211SUPPL1900-01-01
51210SUPPL1900-01-01