Drug application

RILUZOLE (RILUZOLE)

Drugs@FDA ANDA 204048 · ALKEM LABS LTD

Key facts

Drug name RILUZOLE
Active ingredients RILUZOLE
Application type ANDA
Application number 204048
Company ALKEM LABS LTD
Dosage forms TABLET, ORAL
Strength 50MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 30, 2016

At a glance

  • 1–9 Submissions
  • 1–9 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

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