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Last Updated: July 10, 2020

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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 Co and is included in two NDAs. It is available from one supplier. 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. One supplier is 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 ActionCystine 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:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 11, 1988TE: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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