Drug application

THIOLA EC (TIOPRONIN)

Drugs@FDA NDA 211843 · MISSION PHARMACAL

Key facts

Drug name THIOLA EC
Active ingredients TIOPRONIN
Application type NDA
Application number 211843
Company MISSION PHARMACAL
Dosage forms TABLET, DELAYED RELEASE, ORAL
Strength 100MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Jun 28, 2019

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 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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