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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209125
Company: EUGIA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLEDRONIC ACID ZOLEDRONIC ACID EQ 5MG BASE/100ML INJECTABLE;INTRAVENOUS Discontinued 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
12/08/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

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