Prevents cystine stone formation. NDA 19569, held by Mission Pharma. Tiopronin.
As of Nov 13, 2026, NDA 19569 (Thiola), held by Mission Pharma, was first approved by FDA on Aug 11, 1988, with 3 approved supplements and 0 published complete response letters.
THIOLA is 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. --------------------------------------------INDICATIONS AND USAGE-----------------------------------------
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thiola100MG · tablet;oral | Tiopronin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Oct 1, 2001 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 15, 2000 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 11, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
