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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214662

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LIVMARLI (MARALIXIBAT CHLORIDE)
EQ 9.5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: MARALIXIBAT CHLORIDE
Proprietary Name: LIVMARLI
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 9.5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214662
Product Number: 001
Approval Date: Sep 29, 2021
Applicant Holder Full Name: MIRUM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LIVMARLI (MARALIXIBAT CHLORIDE)
EQ 19MG BASE/ML
Marketing Status: Prescription
Active Ingredient: MARALIXIBAT CHLORIDE
Proprietary Name: LIVMARLI
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 19MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214662
Product Number: 002
Approval Date: Jul 24, 2024
Applicant Holder Full Name: MIRUM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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