Details for New Drug Application (NDA): 216990
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NDA 216990 describes TIOPRONIN, which is a drug marketed by Amneal, Par Pharm, Torrent, Par Pharm Inc, and Teva Pharms Usa Inc, and is included in five NDAs. It is available from three 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. Four suppliers are listed for this compound. 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. Four suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
Pharmacology for NDA: 216990
| Mechanism of Action | Cystine 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: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 30, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jan 30, 2024 | TE: | AB | RLD: | No | ||||
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