Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214927
Company: ZEVRA DENMARK

Products on NDA 214927

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 47MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 62MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 93MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 124MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/2024	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214927s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214927Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/214927Orig1s000TOC.cfm

Labels for NDA 214927

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214927s000lbl.pdf