Details for New Drug Application (NDA): 217219
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The generic ingredient in TIOPRONIN is tiopronin. There are three drug master file entries for this compound. Seven 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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