Prevents cystine stone formation. NDA 211843, held by Mission Pharmacal. Tiopronin.
As of Nov 13, 2026, NDA 211843 (Thiola Ec), held by Mission Pharmacal, was first approved by FDA on Jun 28, 2019, with 1 approved supplement and 0 published complete response letters.
Tiopronin Delayed-Release 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 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Mar 8, 2021 | Supplement 2Labeling · Standard review | Approved | |
| Jun 28, 2019 | Original applicationNew dosage form · Standard review | Approved |
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
