Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091186
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) 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
03/04/2013 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
07/11/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/21/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/06/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/06/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/06/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ZOLEDRONIC ACID

INJECTABLE;IV (INFUSION); EQ 4MG BASE/5ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 4MG BASE/5ML INJECTABLE;IV (INFUSION) Prescription No AP 091186 DR REDDYS LABS LTD

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