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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091363
Company: DR REDDYS LABS LTD
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
03/29/2013 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/091363Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/02/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/09/2015 SUPPL-1 Labeling-Package Insert

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
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 202163 BRECKENRIDGE
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 204217 GLAND
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Prescription No AP 209578 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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