Drug application

ZOLEDRONIC ACID (ZOLEDRONIC ACID)

Drugs@FDA ANDA 205254 · MYLAN LABS LTD

Key facts

Drug name ZOLEDRONIC ACID
Active ingredients ZOLEDRONIC ACID
Application type ANDA
Application number 205254
Company MYLAN LABS LTD
Dosage forms INJECTABLE, INTRAVENOUS
Strength EQ 5MG BASE/100ML
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Oct 27, 2017

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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