Tiopronin

Prevents cystine stone formation. ANDA 216278, held by Amneal. Tiopronin.

As of Nov 15, 2026, ANDA 216278 (Tiopronin), held by Amneal, was first approved by FDA on Aug 15, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 15, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 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 EC (tiopronin) delayed-release tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 15, 2023	Original application	Approved	None posted

Products

2 strengths and forms


Tiopronin300MG · tablet, delayed release;oral	Tiopronin	Discontinued
Tiopronin100MG · tablet, delayed release;oral	Tiopronin	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 29, 2025	Supplement 2Manufacturing	Approved	None posted
Aug 15, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 216278
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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