Details for New Drug Application (NDA): 214326
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NDA 214326 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.
Summary for 214326
| Tradename: | TIOPRONIN |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | tiopronin |
| Patents: | 0 |
Pharmacology for NDA: 214326
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 214326
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIOPRONIN | tiopronin | TABLET;ORAL | 214326 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7909 | 0093-7909-01 | 100 TABLET, SUGAR COATED in 1 BOTTLE (0093-7909-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 26, 2021 | TE: | AB | RLD: | No | ||||
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