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Active ingredient

Tiopronin

16 finished FDA listings contain Tiopronin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TIOPRONIN
Dosage forms
Tablet, Delayed Release, Tablet, Sugar Coated
Routes
Oral
Manufacturers / labelers
8
Strengths listed
100 mg/1 · 300 mg/1
Brand names in FDA listings
Thiola, Thiola Ec, Venxxiva

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6765

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 019569MISSION PHARMA1988-08-112
NDA 211843MISSION PHARMACAL2019-06-284
ANDA 214326TEVA PHARMS USA INC2021-04-261
ANDA 217219PH HEALTH2023-02-242
ANDA 216278AMNEAL2023-08-151
ANDA 216990TORRENT2024-01-304
ANDA 216456TEVA PHARMS INC2024-07-222

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.