← FDA DRUG APPROVALS

FDA NDA · NDA214927

MIPLYFFA

arimoclomol citrate

Sponsor: ZEVRA DENMARK

APPLICATION
NDA214927
TYPE
NDA
ORIGINAL APPROVAL
2024-09-20
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MIPLYFFA · ReferencePrescription
ARIMOCLOMOL CITRATE EQ 124MG BASE · CAPSULE · ORAL
MIPLYFFA · ReferencePrescription
ARIMOCLOMOL CITRATE EQ 62MG BASE · CAPSULE · ORAL
MIPLYFFA · ReferencePrescription
ARIMOCLOMOL CITRATE EQ 93MG BASE · CAPSULE · ORAL
MIPLYFFA · ReferencePrescription
ARIMOCLOMOL CITRATE EQ 47MG BASE · CAPSULE · ORAL

Approval history

2024-09-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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