Application Information

This drug has been submitted to the FDA under the reference 078475/001.

Names and composition

"ZOLEDRONIC ACID" is the commercial name of a drug composed of ZOLEDRONIC ACID.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
078475/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 4MG per 5ML(0.8MG per ML)
078533/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per 5ML
078576/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per VIAL
078580/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per VIAL
090018/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per VIAL
090330/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per 5ML
090621/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
090709/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per 5ML
091170/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
091186/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
091187/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ INJECTION 4MMG
091363/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
091364/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ INJECTION 5MG per 100ML
091493/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
091516/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
200918/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
201783/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
201801/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202163/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202182/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202472/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202548/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202571/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202650/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202746/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202828/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202837/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202923/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202930/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
203231/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 100ML
203344/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 4MG per 5ML
203841/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
204016/001 ZOLEDRONIC ACID ZOLEDRONIC ACID SOLUTION/IV (INFUSION) EQ 4MG BASE per 100ML (EQ 0.04MG BASE per ML)
204051/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 4MG per 100ML
204138/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 5MG per 100ML
204217/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
204367/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
205279/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
205749/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
205749/002 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 100ML
207751/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
021223/001 ZOMETA ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021223/002 ZOMETA ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
021223/003 ZOMETA ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 100ML
021386/001 ZOMETA ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per VIAL
021817/001 RECLAST ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
022080/001 RECLAST ZOLEDRONIC ACID INJECTABLE/ INJECTION 5MG per 100ML
078475/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 4MG per 5ML(0.8MG per ML)
078533/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per 5ML
078576/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per VIAL
078580/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per VIAL
090018/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per VIAL
090330/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per 5ML
090621/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
090709/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ IV (INFUSION) EQ 4MG BASE per 5ML
091170/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
091186/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
091187/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ INJECTION 4MMG
091363/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
091364/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/ INJECTION 5MG per 100ML
091493/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
091516/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
200918/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
201783/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
201801/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202163/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202182/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202472/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202548/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202571/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202650/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202746/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202828/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202837/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
202923/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
202930/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
203231/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 100ML
203344/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 4MG per 5ML
203841/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
204016/001 ZOLEDRONIC ACID ZOLEDRONIC ACID SOLUTION/IV (INFUSION) EQ 4MG BASE per 100ML (EQ 0.04MG BASE per ML)
204051/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 4MG per 100ML
204138/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/INJECTION 5MG per 100ML
204217/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
204367/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 5MG BASE per 100ML
205279/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
205749/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML
205749/002 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 100ML
207751/001 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE/IV (INFUSION) EQ 4MG BASE per 5ML

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