Details for New Drug Application (NDA): 216456
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NDA 216456 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 are three drug master file entries 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 are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
Summary for 216456
| Tradename: | TIOPRONIN |
| Applicant: | Teva Pharms Inc |
| Ingredient: | tiopronin |
| Patents: | 0 |
Pharmacology for NDA: 216456
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 216456
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 216456 | ANDA | Teva Pharmaceuticals, Inc. | 0480-7824 | 0480-7824-98 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-7824-98) |
| TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 216456 | ANDA | Teva Pharmaceuticals, Inc. | 0480-9227 | 0480-9227-55 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-9227-55) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | AB | RLD: | No | ||||
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