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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211843


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NDA 211843 describes THIOLA EC, which is a drug marketed by Mission Pharmacal Co and is included in one NDA. It is available from one supplier. Additional details are available on the THIOLA EC profile page.

The generic ingredient in THIOLA EC 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 211843
Tradename:THIOLA EC
Applicant:Mission Pharmacal Co
Ingredient:tiopronin
Patents:0
Pharmacology for NDA: 211843
Mechanism of ActionCystine Disulfide Reduction
Suppliers and Packaging for NDA: 211843
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIOLA EC tiopronin TABLET, DELAYED RELEASE;ORAL 211843 NDA Mission Pharmacal Company 0178-0901 0178-0901-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)
THIOLA EC tiopronin TABLET, DELAYED RELEASE;ORAL 211843 NDA Mission Pharmacal Company 0178-0902 0178-0902-01 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Jun 28, 2019TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength300MG
Approval Date:Jun 28, 2019TE:RLD:Yes

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