Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217785

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REZDIFFRA (RESMETIROM)
60MG
Marketing Status: Prescription

Active Ingredient: RESMETIROM
Proprietary Name: REZDIFFRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217785
Product Number: 001
Approval Date: Mar 14, 2024
Applicant Holder Full Name: MADRIGAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

REZDIFFRA (RESMETIROM)
80MG
Marketing Status: Prescription

Active Ingredient: RESMETIROM
Proprietary Name: REZDIFFRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217785
Product Number: 002
Approval Date: Mar 14, 2024
Applicant Holder Full Name: MADRIGAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

REZDIFFRA (RESMETIROM)
100MG
Marketing Status: Prescription

Active Ingredient: RESMETIROM
Proprietary Name: REZDIFFRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217785
Product Number: 003
Approval Date: Mar 14, 2024
Applicant Holder Full Name: MADRIGAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information