Active substance
Tiopronin
- US FDA 9
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| THIOLA | 100MG | tablet · oral | MISSION PHARMA | Prescription | 11 Aug 1988 |
| THIOLA EC | 100MG; 300MG | tablet, delayed release · oral | MISSION PHARMACAL | Prescription | 28 Jun 2019 |
| TIOPRONIN | 100MG | tablet · oral | TEVA PHARMS USA INC | Prescription | 26 Apr 2021 |
| TIOPRONIN | 100MG; 300MG | tablet, delayed release · oral | PH HEALTH | Prescription | 24 Feb 2023 |
| VENXXIVA | 100MG; 300MG | tablet, delayed release · oral | TORRENT | Prescription | 30 Jan 2024 |
| TIOPRONIN | 100MG; 300MG | tablet, delayed release · oral | TEVA PHARMS INC | Prescription | 22 Jul 2024 |
| TIOCYSTIN | 100MG; 200MG | tablet · oral | CASPER PHARMA LLC | Prescription | 2 Jun 2026 |
| TIOPRONIN | 100MG | tablet · oral | PH HEALTH | Discontinued | 2 Jun 2022 |
| TIOPRONIN | 300MG; 100MG | tablet, delayed release · oral | AMNEAL | Discontinued | 15 Aug 2023 |
Safety signals and safety-related labeling changes
- US FDA 8 Mar 2021 THIOLA EC — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Jun 2019 THIOLA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.