Details for New Drug Application (NDA): 216278
NDA 216278 describes TIOPRONIN, which is a drug marketed by Amneal, Ph Health, Teva Pharms Inc, and Teva Pharms Usa Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the TIOPRONIN profile page.
The generic ingredient in TIOPRONIN is tiopronin. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
The generic ingredient in TIOPRONIN is tiopronin. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
Pharmacology for NDA: 216278
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 216278
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 216278 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2009 | 60219-2009-9 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 15, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 29, 2025 | TE: | RLD: | No | |||||
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