Drug application

FINGOLIMOD HYDROCHLORIDE (FINGOLIMOD HYDROCHLORIDE)

Drugs@FDA ANDA 207993 · APOTEX

Key facts

Drug name FINGOLIMOD HYDROCHLORIDE
Active ingredients FINGOLIMOD HYDROCHLORIDE
Application type ANDA
Application number 207993
Company APOTEX
Dosage forms CAPSULE, ORAL
Strength EQ 0.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 18, 2020

At a glance

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