Drug application

VYNDAMAX (TAFAMIDIS)

Drugs@FDA NDA 212161 · FOLDRX PHARMS

Key facts

Drug name VYNDAMAX
Active ingredients TAFAMIDIS
Application type NDA
Application number 212161
Company FOLDRX PHARMS
Dosage forms CAPSULE, ORAL
Strength 61MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 2 - New Active Ingredient
Latest submission status date May 3, 2019

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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