Drug application

RISPERIDONE (RISPERIDONE)

Drugs@FDA ANDA 078116 · SANDOZ

Key facts

Drug name RISPERIDONE
Active ingredients RISPERIDONE
Application type ANDA
Application number 078116
Company SANDOZ
Dosage forms TABLET, ORALLY DISINTEGRATING, ORAL
Strength 0.5MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 22, 2009

At a glance

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