Drug application

BAFIERTAM (MONOMETHYL FUMARATE)

Drugs@FDA NDA 210296 · BANNER LIFE SCIENCES

Key facts

Drug name BAFIERTAM
Active ingredients MONOMETHYL FUMARATE
Application type NDA
Application number 210296
Company BANNER LIFE SCIENCES
Dosage forms CAPSULE, DELAYED RELEASE, ORAL
Strength 95MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 2 - New Active Ingredient
Latest submission status date Apr 28, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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