Ibandronate Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sun Pharmaceutical Industries Limited (2015-05-21)
Oldest Current Product
2014-02-15
License(s)
ANDA
RxNORM
INJECTION\IBANDRONATE
FDAOB
INTRAVENOUS\INJECTION\IBANDRONATE SODIUM
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\IBANDRONATE SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\IBANDRONIC ACID

product(s) by strength(s)

3 ml ibandronic acid 1 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550162ANDAHeritage Pharmaceuticals Inc.2014-09-04IBANDRONATE SODIUMINTRAVENOUSINJECTION, SOLUTIONANDA2039879531b609-61df-4b77-be09-7469fc30ee2d
2627560218ANDASun Pharmaceutical Industries Limited2014-02-15IBANDRONATE SODIUMINTRAVENOUSINJECTION, SOLUTIONANDA090853be514be6-727a-4d6c-993b-52144f8e6de8

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA090853IBANDRONATE SODIUMSUN PHARMACEUTICAL INDUSTRIES LTD2014-02-14ANDA090853_001Ibandronate Prefilled Syringe
2ANDA202235IBANDRONATE SODIUMSAGENT PHARMACEUTICALS INC2014-09-02ANDA202235_001Ibandronate Prefilled Syringe
3ANDA202671IBANDRONATE SODIUMMYLAN LABORATORIES LTD2014-09-02ANDA202671_001Ibandronate Prefilled Syringe
4ANDA203987IBANDRONATE SODIUMEMCURE PHARMACEUTICALS LTD2014-09-02ANDA203987_001Ibandronate Prefilled Syringe
5ANDA204222IBANDRONATE SODIUMAPOTEX INC2015-10-16ANDA204222_001Ibandronate Prefilled Syringe
6ANDA205332IBANDRONATE SODIUMAUROBINDO PHARMA LTD2015-08-19ANDA205332_001Ibandronate Prefilled Syringe
7NDA021858BONIVAHOFFMANN LA ROCHE INC2006-01-06p5662918, SUBSTANCENDA021858_001Ibandronate Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090853_001RXIBANDRONATE SODIUM (EQ 3MG BASE/3ML)INTRAVENOUSINJECTIONFalseAP2014-02-14IBANDRONATE SODIUM
2ANDA202235_001RXIBANDRONATE SODIUM (EQ 3MG BASE/3ML)INTRAVENOUSINJECTIONFalseAP2014-09-02IBANDRONATE SODIUM
3ANDA202671_001RXIBANDRONATE SODIUM (EQ 3MG BASE/3ML)INTRAVENOUSINJECTIONFalseAP2014-09-02IBANDRONATE SODIUM
4ANDA203987_001RXIBANDRONATE SODIUM (EQ 3MG BASE/3ML)INTRAVENOUSINJECTIONFalseAP2014-09-02IBANDRONATE SODIUM
5ANDA204222_001RXIBANDRONATE SODIUM (EQ 3MG BASE/3ML)INTRAVENOUSINJECTIONFalseAP2015-10-16IBANDRONATE SODIUM
6ANDA205332_001RXIBANDRONATE SODIUM (EQ 3MG BASE/3ML)INTRAVENOUSINJECTIONFalseAP2015-08-19IBANDRONATE SODIUM
7NDA021858_001RXIBANDRONATE SODIUM (EQ 3MG BASE/3ML)INTRAVENOUSINJECTIONTrueAP2006-01-06BONIVA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5662918 (view patent)2014-09-02NDA021858Ibandronate Prefilled Syringe

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19531b609-61df-4b77-be09-7469fc30ee2d (view SPL)These highlights do not include all the information needed to use ibandronate sodium injection safely and effectively. See full prescribing information for ibandronate sodium injection. Ibandronate sodium injection, for intravenous use Initial U.S. Approval: 2003prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-07-027231550162
2be514be6-727a-4d6c-993b-52144f8e6de8 (view SPL)These highlights do not include all the information needed to use ibandronate sodium injection safely and effectively. See full prescribing information for ibandronate sodium injection. IBANDRONATE sodium injection, for intravenous use Initial U.S. Approval: 2003prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-214627560218

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