Details for New Drug Application (NDA): 019569
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NDA 019569 describes THIOLA, which is a drug marketed by Mission Pharma and Mission Pharmacal and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the THIOLA profile page.
The generic ingredient in THIOLA 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 THIOLA 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 019569
| Tradename: | THIOLA |
| Applicant: | Mission Pharma |
| Ingredient: | tiopronin |
| Patents: | 0 |
Pharmacology for NDA: 019569
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 019569
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIOLA | tiopronin | TABLET;ORAL | 019569 | NDA | Mission Pharmacal Company | 0178-0900 | 0178-0900-01 | 100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 11, 1988 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jun 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED IN COMBINATION WITH HIGH FLUID INTAKE, ALKALI, AND DIET MODIFICATION, FOR THE PREVENTION OF CYSTINE STONE FORMATION IN PEDIATRIC PATIENTS 20KG TO 9 YEARS OF AGE W/SEVERE HOMOZYGOUS CYSTINURIA, WHO ARE NOT RESPONSIVE TO THESE MEASURES ALONE | ||||||||
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