Details for New Drug Application (NDA): 217219
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NDA 217219 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
Summary for 217219
| Tradename: | TIOPRONIN |
| Applicant: | Endo Operations |
| Ingredient: | tiopronin |
| Patents: | 0 |
Pharmacology for NDA: 217219
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 217219
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 217219 | ANDA | ENDO USA, Inc. | 0254-3034 | 0254-3034-30 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3034-30) |
| TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 217219 | ANDA | ENDO USA, Inc. | 0254-3035 | 0254-3035-09 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 24, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Feb 24, 2023 | TE: | AB | RLD: | No | ||||
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