Drug application

DTIC-DOME (DACARBAZINE)

Drugs@FDA NDA 017575 · BAYER HLTHCARE

Key facts

Drug name DTIC-DOME
Active ingredients DACARBAZINE
Application type NDA
Application number 017575
Company BAYER HLTHCARE
Dosage forms INJECTABLE, INJECTION
Strength 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date May 27, 1975

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 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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