Drug application

TEMOZOLOMIDE (TEMOZOLOMIDE)

Drugs@FDA ANDA 078879 · HERITAGE

Key facts

Drug name TEMOZOLOMIDE
Active ingredients TEMOZOLOMIDE
Application type ANDA
Application number 078879
Company HERITAGE
Dosage forms CAPSULE, ORAL
Strength 5MG
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Mar 1, 2010

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • No FDA letters on file
  • Yes FDA reviews on file

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 · Source date:

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