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ZTALMY

NDA · New Drug Application · Sponsor: IMMEDICA PHARMA · Approved 2022-03-18

Drug application

FDA Application #

NDA215904

Application type

New Drug Application

Brand name

ZTALMY

Generic name

GANAXOLONE

Active ingredients

GANAXOLONE

Dosage form

SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

IMMEDICA PHARMA

Manufacturer

Immedica Pharma US Inc

First approval

2022-03-18

Source

Authoritative

Drugs@FDA application overview

Machine

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