Orange Book product · Brand (NDA)
THIOLA
TIOPRONIN
At a glance
Aug 11, 1988
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 11, 1988
38 yr 5 mo ago
Today
Exclusivity ends · ODE-267
Orphan-drug exclusivity (7 years)
Jun 28, 2026
in 9 d
Pharmaceutical detail
Active ingredient
TIOPRONIN
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019569
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019THIOLA ECBrand (NDA)
NDA 211843 · MISSION PHARMACAL
- 2025TIOPRONINGeneric (ANDA)
ANDA 216278 · AMNEAL
- 2024TIOPRONINGeneric (ANDA)
ANDA 216456 · TEVA PHARMS INC
- 2024VENXXIVAGeneric (ANDA)
ANDA 216990 · TORRENT
- 2023TIOPRONINGeneric (ANDA)
ANDA 217219 · PH HEALTH
- 2022TIOPRONINGeneric (ANDA)
ANDA 216198 · PH HEALTH
- 2021TIOPRONINGeneric (ANDA)
ANDA 214326 · TEVA PHARMS USA INC
Marketing exclusivity (1)
- ODE-267Orphan-drug exclusivity (7 years)
Jun 28, 2026
in 9 d
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
