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FDA NDA · NDA217159

APHEXDA

motixafortide

Sponsor: AYRMID PHARMA

APPLICATION
NDA217159
TYPE
NDA
ORIGINAL APPROVAL
2023-09-08
LATEST ACTION
2026-03-11
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

APHEXDA · ReferencePrescription
MOTIXAFORTIDE ACETATE EQ 62MG BASE/VIAL · POWDER · SUBCUTANEOUS

Approval history

2026-03-11Labeling · Supplement 9 · standardLabelAP
2023-09-08Type 1 - New Molecular Entity · Original · standardLetterAP
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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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