AGAMREE (VAMOROLONE)
Summary
FDA approved AGAMREE (VAMOROLONE) by CATALYST PHARMS. NDA (New Drug) approval (Labeling) on 2024-06-05. SUSPENSION, ORAL.
Details
Source
Drug Approval
External ID
NDA215239-1
Action Date
2024-06-05
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
AGAMREE (generic: VAMOROLONE), SUSPENSION, ORAL. Application: NDA215239
Company
Context & Analysis
CATALYST PHARMS has 2 FDA actions in our database.
Frequently Asked Questions
How often does CATALYST PHARMS have FDA actions?
CATALYST PHARMS has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA215239-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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