Drug application

ZOLEDRONIC ACID (ZOLEDRONIC ACID)

Drugs@FDA ANDA 216534 · SHANDONG NEW TIME PHARMACEUTICAL CO LTD

Key facts

Drug name ZOLEDRONIC ACID
Active ingredients ZOLEDRONIC ACID
Application type ANDA
Application number 216534
Company SHANDONG NEW TIME PHARMACEUTICAL CO LTD
Dosage forms INJECTABLE, INJECTION
Strength 4MG/5ML(0.8MG/ML)
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Mar 27, 2024

At a glance

  • 1–9 Submissions
  • None Label versions
  • None Products
  • None 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

Browse all Drugs@FDA applications