Iron-Dextran Complex Injectable Solution

Brand(s)
Dexferrum, InFed
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2014-07-10)
Oldest Current Product
1974-04-29
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\IRON-DEXTRAN COMPLEX
FDAOB
INJECTION\INJECTION\IRON DEXTRAN\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\IRON DEXTRAN
INTRAMUSCULAR\INJECTION\IRON DEXTRAN
INTRAVENOUS\INJECTION, SOLUTION\IRON DEXTRAN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\IRON
INTRAMUSCULAR\INJECTION\FERRIC CATION
INTRAVENOUS\INJECTION, SOLUTION\FERRIC CATION

product(s) by strength(s)

iron-dextran complex 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170134DexferrumNDAAmerican Regent, Inc.1998-10-01IRON DEXTRANINTRAVENOUSINJECTION, SOLUTIONNDA04002477f5ae2a-8cd3-4f01-bddd-8158f932c8db
2525440931InFedNDAActavis Pharma, Inc.1974-04-29IRON DEXTRANINTRAMUSCULARINJECTIONNDA017441abacb7fa-2fc2-471e-9200-944eeac8ca2a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840931InFedNDAGeneral Injecatables & Vaccines, Inc2010-09-01IRON DEXTRANINTRAMUSCULARINJECTION, SOLUTION525440931NDA01744106e33e48-0c96-4f34-bbfb-39d29ea97dde

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA010787IRON DEXTRANTrueSANOFI AVENTIS US LLCNDA010787_002
2NDA017441INFEDACTAVIS LABORATORIES UT INCNDA017441_001
3NDA017807PROFERDEXNEW RIVER PHARMACEUTICALS INCNDA017807_001
4NDA040024DEXFERRUMLUITPOLD PHARMACEUTICALS INC1996-02-23p5624668NDA040024_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1NDA010787_002discontinuedIRON DEXTRAN (EQ 50MG IRON/ML)INJECTIONFalseIRON DEXTRAN
2NDA017441_001RXIRON DEXTRAN (EQ 50MG IRON/ML)INJECTIONTrueBPINFED
3NDA017807_001RXIRON DEXTRAN (EQ 50MG IRON/ML)INJECTIONFalseBPPROFERDEX
4NDA040024_001RXIRON DEXTRAN (EQ 50MG IRON/ML)INJECTIONFalseBP1996-02-23DEXFERRUM

patent(s)

#idexpiration dateapplication(s)
1p5624668 (view patent)2015-09-29NDA040024

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106e33e48-0c96-4f34-bbfb-39d29ea97dde (view SPL)Infed (Iron Dextran) 20 mg/mL Injection, USP 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-06-133525840931
277f5ae2a-8cd3-4f01-bddd-8158f932c8db (view SPL)DEXFERRUM (IRON DEXTRAN INJECTION, USP)prescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-04-026005170134, 005170234
3abacb7fa-2fc2-471e-9200-944eeac8ca2a (view SPL)INFeD(IRON DEXTRAN INJECTION USP)Rx onlyRevised: January 2014255769prescriptionHuman PrescriptionActavis Pharma, Inc.2014-07-105525440931

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