Orange Book product · Generic (ANDA)
TIOPRONIN
TIOPRONIN
At a glance
Aug 29, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2025
10 mo ago
Today
Pharmaceutical detail
Active ingredient
TIOPRONIN
Strength
100MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 216278
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TIOPRONIN
- 2019THIOLA ECBrand (NDA)
NDA 211843 · MISSION PHARMACAL
- 1988THIOLABrand (NDA)
NDA 019569 · MISSION PHARMA
- 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
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.

