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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 216990


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NDA 216990 describes TIOPRONIN, which is a drug marketed by Amneal, Endo Operations, Teva Pharms Inc, Torrent, and Teva Pharms Usa Inc, and is included in six NDAs. It is available from five suppliers. Additional details are available on the TIOPRONIN profile page.

The generic ingredient in TIOPRONIN is tiopronin. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
Summary for 216990
Tradename:TIOPRONIN
Applicant:Torrent
Ingredient:tiopronin
Patents:0
Pharmacology for NDA: 216990
Mechanism of ActionCystine Disulfide Reduction
Suppliers and Packaging for NDA: 216990
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIOPRONIN tiopronin TABLET, DELAYED RELEASE;ORAL 216990 ANDA Torrent Pharmaceuticals Limited 13668-691 13668-691-03 300 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-691-03)
TIOPRONIN tiopronin TABLET, DELAYED RELEASE;ORAL 216990 ANDA Torrent Pharmaceuticals Limited 13668-692 13668-692-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-692-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Jan 30, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength300MG
Approval Date:Jan 30, 2024TE:ABRLD:No

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