Drug application

FINGOLIMOD (FINGOLIMOD)

Drugs@FDA ANDA 207940 · STANDARD CHEM AND PHARM CO LTD

Key facts

Drug name FINGOLIMOD
Active ingredients FINGOLIMOD
Application type ANDA
Application number 207940
Company STANDARD CHEM AND PHARM CO LTD
Dosage forms CAPSULE, ORAL
Strength EQ 0.5MG BASE
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date May 11, 2021

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None 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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