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Last Updated: December 5, 2019

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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
Applicant:Mission Pharma
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

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