Prevents cystine stone formation. ANDA 214326, held by Teva Pharms USA Inc. Tiopronin.
As of Nov 15, 2026, ANDA 214326 (Tiopronin), held by Teva Pharms USA Inc, was first approved by FDA on Apr 26, 2021, with 0 approved supplements and 0 published complete response letters.
Tiopronin tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola (tiopronin) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tiopronin100MG · tablet;oral | Tiopronin | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
