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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211843

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THIOLA EC (TIOPRONIN)
100MG
Marketing Status: Prescription
Active Ingredient: TIOPRONIN
Proprietary Name: THIOLA EC
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N211843
Product Number: 001
Approval Date: Jun 28, 2019
Applicant Holder Full Name: MISSION PHARMACAL CO
Marketing Status:  Prescription
Patent and Exclusivity Information
THIOLA EC (TIOPRONIN)
300MG
Marketing Status: Prescription
Active Ingredient: TIOPRONIN
Proprietary Name: THIOLA EC
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N211843
Product Number: 002
Approval Date: Jun 28, 2019
Applicant Holder Full Name: MISSION PHARMACAL CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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