Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214927

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MIPLYFFA (ARIMOCLOMOL CITRATE)
EQ 47MG BASE
Marketing Status: Prescription

Active Ingredient: ARIMOCLOMOL CITRATE
Proprietary Name: MIPLYFFA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 47MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214927
Product Number: 001
Approval Date: Sep 20, 2024
Applicant Holder Full Name: ZEVRA DENMARK AS
Marketing Status:  Prescription
Patent and Exclusivity Information

MIPLYFFA (ARIMOCLOMOL CITRATE)
EQ 62MG BASE
Marketing Status: Prescription

Active Ingredient: ARIMOCLOMOL CITRATE
Proprietary Name: MIPLYFFA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 62MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214927
Product Number: 002
Approval Date: Sep 20, 2024
Applicant Holder Full Name: ZEVRA DENMARK AS
Marketing Status:  Prescription
Patent and Exclusivity Information

MIPLYFFA (ARIMOCLOMOL CITRATE)
EQ 93MG BASE
Marketing Status: Prescription

Active Ingredient: ARIMOCLOMOL CITRATE
Proprietary Name: MIPLYFFA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 93MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214927
Product Number: 003
Approval Date: Sep 20, 2024
Applicant Holder Full Name: ZEVRA DENMARK AS
Marketing Status:  Prescription
Patent and Exclusivity Information

MIPLYFFA (ARIMOCLOMOL CITRATE)
EQ 124MG BASE
Marketing Status: Prescription

Active Ingredient: ARIMOCLOMOL CITRATE
Proprietary Name: MIPLYFFA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 124MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214927
Product Number: 004
Approval Date: Sep 20, 2024
Applicant Holder Full Name: ZEVRA DENMARK AS
Marketing Status:  Prescription
Patent and Exclusivity Information