Drug application

FINGOLIMOD HYDROCHLORIDE (FINGOLIMOD HYDROCHLORIDE)

Drugs@FDA ANDA 212152 · TEVA PHARMS USA

Key facts

Drug name FINGOLIMOD HYDROCHLORIDE
Active ingredients FINGOLIMOD HYDROCHLORIDE
Application type ANDA
Application number 212152
Company TEVA PHARMS USA
Dosage forms CAPSULE, ORAL
Strength EQ 0.25MG BASE
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Nov 12, 2021

At a glance

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