Details for New Drug Application (NDA): 216456
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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 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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