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AGAMREE

NDA · New Drug Application · Sponsor: CATALYST PHARMS · Approved 2023-10-26

Drug application

FDA Application #

NDA215239

Application type

New Drug Application

Brand name

AGAMREE

Generic name

VAMOROLONE

Active ingredients

VAMOROLONE

Dosage form

SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

CATALYST PHARMS

Manufacturer

Catalyst Pharmaceuticals, Inc.

First approval

2023-10-26

Source

Authoritative

Drugs@FDA application overview

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