ferric carboxymaltose Injectable Solution

Brand(s)
Injectafer
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2013-07-29)
Oldest Current Product
2013-08-12
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\FERRIC CARBOXYMALTOSE
FDAOB
INTRAVENOUS\INJECTION\FERRIC CARBOXYMALTOSE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\FERRIC CARBOXYMALTOSE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FERRIC CATION

product(s) by strength(s)

ferric carboxymaltose 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170650InjectaferNDAAmerican Regent, Inc.2013-08-12FERRIC CARBOXYMALTOSEINTRAVENOUSINJECTION, SOLUTIONNDA203565517b4a19-45b3-4286-9f6a-ced4e10447de

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203565INJECTAFERLUITPOLD PHARMACEUTICALS INC2013-07-25p8895612, METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, SUBSTANCE
p7754702, METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, SUBSTANCE
p7612109, SUBSTANCE
NEW PRODUCT [2016-07-25]NDA203565_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203565_001RXFERRIC CARBOXYMALTOSE (750MG IRON/15ML)INTRAVENOUSINJECTIONTrue2013-07-25INJECTAFER

patent(s)

#idexpiration dateapplication(s)
1p7612109 (view patent)2024-02-05NDA203565
2p7754702 (view patent)2027-02-13NDA203565
3p8895612 (view patent)2027-01-08NDA203565

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1517b4a19-45b3-4286-9f6a-ced4e10447de (view SPL)These highlights do not include all the information needed to use Injectafer safely and effectively. See full prescribing information for Injectafer. INJECTAFER (ferric carboxymaltose injection) For intravenous use Initial U.S. Approval: 2013prescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2013-07-293005170650

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII