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ACTIVE SUBSTANCE / INN

IBANDRONATE SODIUM

Brand name(s): IBANDRONATE SODIUM, BONIVA
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA021858
ANDA078948
ACTIVE SUBSTANCE
Ibandronate Sodium
REGULATORS
FDA
SPONSORS / MAH
PHARMOBEDIENT, ROCHE, APOTEX INC
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
IBANDRONATE SODIUMANDA078995PHARMOBEDIENTDiscontinued
BONIVANDA021858ROCHEDiscontinued
IBANDRONATE SODIUMANDA078948APOTEX INCPrescription
IBANDRONATE SODIUMANDA079002COBALT LABS INCNone (Tentative Approval)

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