Drug application

MITOXANTRONE HYDROCHLORIDE (MITOXANTRONE HYDROCHLORIDE)

Drugs@FDA ANDA 078606 · FRESENIUS KABI ONCOL

Key facts

Drug name MITOXANTRONE HYDROCHLORIDE
Active ingredients MITOXANTRONE HYDROCHLORIDE
Application type ANDA
Application number 078606
Company FRESENIUS KABI ONCOL
Dosage forms INJECTABLE, INJECTION
Strength EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Marketing status Discontinued
Reference listed drug No
Latest submission status date May 14, 2008

At a glance

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

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