Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204367
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription AP 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
12/24/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2017 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/25/2017 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS; EQ 5MG BASE/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RECLAST ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription Yes AP 021817 NOVARTIS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 200918 AKORN
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 204367 APOTEX INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 209125 AUROBINDO PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 202163 BRECKENRIDGE PHARM
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 091363 DR REDDYS LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 201801 EMCURE PHARMS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 204217 GLAND PHARMA LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 202837 HOSPIRA INC
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 202828 INFORLIFE
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 203841 MYLAN LABS LTD
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 205254 MYLAN LABS LTD

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