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FDA NDA · NDA215239

AGAMREE

vamorolone

Sponsor: CATALYST PHARMS

APPLICATION
NDA215239
TYPE
NDA
ORIGINAL APPROVAL
2023-10-26
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

AGAMREE · ReferencePrescription
VAMOROLONE 40MG/ML · SUSPENSION · ORAL

Approval history

2024-06-05Labeling · Supplement 1 · standard — Label ↗AP
2023-10-26Type 1 - New Molecular Entity · Original · standard — 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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