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ERZOFRI

NDA · New Drug Application · Sponsor: LUYE INNOMIND PHARMA · Approved 2024-07-26

Drug application

FDA Application #

NDA216352

Application type

New Drug Application

Brand name

ERZOFRI

Generic name

PALIPERIDONE PALMITATE

Active ingredients

PALIPERIDONE PALMITATE

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

Marketing status

Prescription

Sponsor

LUYE INNOMIND PHARMA

Manufacturer

Shandong Luye Pharmaceutical Co., Ltd.

First approval

2024-07-26

Source

Authoritative

Drugs@FDA application overview

Machine

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