ferric oxide, saccharated Injectable Solution

Brand(s)
Venofer
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2014-01-01)
Oldest Current Product
2007-06-12
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\FERRIC OXIDE, SACCHARATED
FDAOB
INTRAVENOUS\INJECTION\IRON SUCROSE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\IRON SUCROSE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FERRIC CATION

product(s) by strength(s)

ferric oxide, saccharated 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005172310VenoferNDAAmerican Regent, Inc.2007-06-12IRON SUCROSEINTRAVENOUSINJECTION, SOLUTIONNDA021135626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a
2005172325VenoferNDAAmerican Regent, Inc.2011-01-27IRON SUCROSEINTRAVENOUSINJECTION, SOLUTIONNDA021135626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a
3492300534VenoferNDAFresenius Medical Care North America2008-11-04IRON SUCROSEINTRAVENOUSINJECTION, SOLUTIONNDA021135f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA021135VENOFERLUITPOLD PHARMACEUTICALS INC2000-11-06NEW PATIENT POPULATION [2015-09-21]NDA021135_001, NDA021135_002, NDA021135_003, NDA021135_004, NDA021135_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021135_001RXIRON SUCROSE (EQ 100MG BASE/5ML)INTRAVENOUSINJECTIONTrue2000-11-06VENOFER
2NDA021135_002RXIRON SUCROSE (EQ 50MG BASE/2.5ML)INTRAVENOUSINJECTIONFalse2005-03-20VENOFER
3NDA021135_003discontinuedIRON SUCROSE (EQ 75MG BASE/3.75ML)INTRAVENOUSINJECTIONFalse2005-03-29VENOFER
4NDA021135_004RXIRON SUCROSE (EQ 200MG BASE/10ML)INTRAVENOUSINJECTIONFalse2007-02-09VENOFER
5NDA021135_005discontinuedIRON SUCROSE (EQ 65MG BASE/3.25ML)INTRAVENOUSINJECTIONFalse2013-03-29VENOFER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a (view SPL)These highlights do not include all the information needed to use VENOFER safely and effectively. See full prescribing information for VENOFER.Venofer (iron sucrose injection, USP)Initial U.S. Approval: 2000prescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, STERILIZE2014-01-0117005172310, 005172325, 005172340
2f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 (view SPL)These highlights do not include all the information needed to use VENOFER safely and effectively. See full prescribing information for VENOFER.Venofer (iron sucrose injection, USP)Initial U.S. Approval: 2000prescriptionHuman PrescriptionFresenius Medical Care North AmericaANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE2013-10-019492300534, 492300530

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