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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205749
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLEDRONIC ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription AP No No
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;IV (INFUSION) None (Tentative Approval) None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/29/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2020 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

ZOLEDRONIC

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLEDRONIC ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 205749 GLAND PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 210174 AMNEAL
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 203231 INFORLIFE
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription Yes AP 021223 NOVARTIS

ZOLEDRONIC ACID

There are no Therapeutic Equivalents.

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