Sodium ferric gluconate complex Injectable Solution

Brand(s)
Ferrlecit, Nulecit
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-04-13)
Oldest Current Product
1999-02-18
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\SODIUM FERRIC GLUCONATE COMPLEX
FDAOB
INJECTION\INJECTION\SODIUM FERRIC GLUCONATE COMPLEX\rdfq
SPL Active
INTRAVENOUS\INJECTION\SODIUM FERRIC GLUCONATE COMPLEX
SPL Moiety
INTRAVENOUS\INJECTION\FERRIC CATION
INTRAVENOUS\INJECTION\FERRIC CATION: IRON
INTRAVENOUS\INJECTION\IRON

product(s) by strength(s)

sodium ferric gluconate complex 12.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000242791FerrlecitNDASanofi-Aventis U.S. Llc1999-02-182014-10-31SODIUM FERRIC GLUCONATE COMPLEXINTRAVENOUSINJECTIONNDA0209551fe028ff-42ac-4329-b1a5-a9dadfcb79f6
2000242794FerrlecitNDASanofi-Aventis U.S. Llc2014-07-07SODIUM FERRIC GLUCONATE COMPLEXINTRAVENOUSINJECTIONNDA020955b25b34ab-9cf1-4a2b-bdf2-5eaf66625999

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439570ANDAWest-Ward Pharmaceutical Corp2011-03-31SODIUM FERRIC GLUCONATE COMPLEXINTRAVENOUSINJECTIONANDA078215218d1b8d-b24f-4f77-b588-97c7dd1c2eec
2005910149ANDAWatson Laboratories, Inc.2011-03-31SODIUM FERRIC GLUCONATE COMPLEXINTRAVENOUSINJECTIONANDA0782152b28ca1b-673e-491b-9421-678c999261b0
3005912508ANDAWatson Laboratories, Inc.2012-08-23SODIUM FERRIC GLUCONATE COMPLEXINTRAVENOUSINJECTIONANDA078215fc374c01-f3ed-4920-920b-b19f20fd20a9
4525440149NulecitANDAActavis Pharma, Inc.2011-03-31SODIUM FERRIC GLUCONATE COMPLEXINTRAVENOUSINJECTIONANDA07821572153161-a533-4e90-b9b8-54090b8816be

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078215SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEEUROHEALTH INTERNATIONAL SARL2011-03-31ANDA078215_001
2NDA020955FERRLECITSANOFI AVENTIS US LLC1999-02-18NDA020955_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078215_001RXSODIUM FERRIC GLUCONATE COMPLEX (62.5MG/5ML)INJECTIONFalseAB2011-03-31SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
2NDA020955_001RXSODIUM FERRIC GLUCONATE COMPLEX (62.5MG/5ML)INJECTIONTrueAB1999-02-18FERRLECIT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11fe028ff-42ac-4329-b1a5-a9dadfcb79f6 (view SPL)These highlights do not include all the information needed to use Ferrlecit safely and effectively. See full prescribing information for Ferrlecit. Ferrlecit (sodium ferric gluconate complex in sucrose injection), For intravenous (IV) use Initial U.S. Approval: 1999prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-04-133000242791, 000242792
2218d1b8d-b24f-4f77-b588-97c7dd1c2eec (view SPL)These highlights do not include all the information needed to usesodium ferric gluconate complex in sucrose injection safely and effectively. See full prescribing information for sodium ferric gluconate complex in sucrose injection. Sodium ferric gluconate complex in sucrose injection, for intravenous (IV)use Initial U.S. Approval: 1999prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2014-11-211001439570
32b28ca1b-673e-491b-9421-678c999261b0 (view SPL)These highlights do not include all the information needed to use sodium ferric gluconate complex in sucrose injection safely and effectively. See full prescribing information for sodium ferric gluconate complex in sucrose injection . S odium ferric gluconate complex in sucrose injection, for intravenous (IV) use Initial U.S. Approval: 1999prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-10-316005910149
472153161-a533-4e90-b9b8-54090b8816be (view SPL)NulecitprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-04-014525440149
5b25b34ab-9cf1-4a2b-bdf2-5eaf66625999 (view SPL)These highlights do not include all the information needed to use Ferrlecit safely and effectively. See full prescribing information for Ferrlecit. Ferrlecit (sodium ferric gluconate complex in sucrose injection), For intravenous (IV) use Initial U.S. Approval: 1999prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-05-231000242794
6fc374c01-f3ed-4920-920b-b19f20fd20a9 (view SPL)These highlights do not include all the information needed to usesodium ferric gluconate complex in sucrose injection safely and effectively. See full prescribing information for sodium ferric gluconate complex in sucrose injection. Sodium ferric gluconate complex in sucrose injection, for intravenous (IV) use Initial U.S. Approval: 1999prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-03-018005912508

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