FDA.reportPublic FDA data

Application 022180

Type
NDA
Sponsor
AMAG PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FERAHEMEFERUMOXYTOLSOLUTION;INTRAVENOUSEQ 510MG IRON/17ML (EQ 30MG IRON/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59338-775FerahemeferumoxytolAMAG Pharmaceuticals, Inc.NDACurrent
59338-775FerahemeferumoxytolAMAG Pharmaceuticals, Inc.NDACurrent
59338-775FerahemeferumoxytolAMAG Pharmaceuticals, Inc.NDACurrent
59338-775FerahemeferumoxytolAMAG Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71358SUPPL2022-06-21
71349SUPPL2022-06-17
64615SUPPL2020-09-21
64570SUPPL2020-09-14
60554SUPPL2019-10-15
60552SUPPL2019-10-15
52508SUPPL2018-02-08
52398SUPPL2018-02-05
50933SUPPL2017-12-27
50910SUPPL2017-12-27
38340SUPPL2015-03-19
17048SUPPL2015-03-19
29359SUPPL2015-03-17
29358SUPPL2015-03-17
17047SUPPL2013-12-24
38339SUPPL2011-06-29
29357SUPPL2011-06-28
38338SUPPL2010-12-01
38337SUPPL2010-12-01
29356SUPPL2010-11-30
7006SUPPL2010-11-30
44693ORIG2009-11-25
42438ORIG2009-11-25
29355ORIG2009-07-07
38336ORIG2009-07-02