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FIRDAPSE

NDA · New Drug Application · Sponsor: CATALYST PHARMS · Approved 2018-11-28

Drug application

FDA Application #

NDA208078

Application type

New Drug Application

Brand name

FIRDAPSE

Generic name

AMIFAMPRIDINE PHOSPHATE

Active ingredients

AMIFAMPRIDINE PHOSPHATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

CATALYST PHARMS

Manufacturer

Catalyst Pharmaceuticals, Inc.

First approval

2018-11-28

Source

Authoritative

Drugs@FDA application overview

Machine

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