NDC 69616-264

Agamree 40 mg per 1 mL kit

On the label: Catalyst Pharmaceuticals, Inc..

Switzerland: 1Belgium: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Allpack Group AGReinach, SwitzerlandMakes it Problems found, fixed voluntarilyApr 28, 2023 · 6 inspections
Purna Pharmaceuticals NVPuurs, BelgiumMakes it Problems found, fixed voluntarilyAug 20, 2025 · 1 inspection

Product details

Generic drug
Vamorolone: every company that makes it
Form
kit, oral
Strength
40 mg per 1 mL
Approval
NDA NDA215239
On the market since
Feb 1, 2024
Package NDCs
69616-264-38 69616-265-38
Official label
DailyMed (National Library of Medicine), updated Jan 22, 2026

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