Drug application

PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE)

Drugs@FDA NDA 217604 · AMNEAL

Key facts

Drug name PYRIDOSTIGMINE BROMIDE
Active ingredients PYRIDOSTIGMINE BROMIDE
Application type NDA
Application number 217604
Company AMNEAL
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 105MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Oct 4, 2024

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:

Browse all Drugs@FDA applications