Drug application

ANZEMET (DOLASETRON MESYLATE)

Drugs@FDA NDA 020623 · VALIDUS PHARMS

Key facts

Drug name ANZEMET
Active ingredients DOLASETRON MESYLATE
Application type NDA
Application number 020623
Company VALIDUS PHARMS
Dosage forms TABLET, ORAL
Strength 50MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Sep 11, 1997

At a glance

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