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GOPRELTO

NDA · New Drug Application · Sponsor: LXO IRELAND · Approved 2017-12-14

Drug application

FDA Application #

NDA209963

Application type

New Drug Application

Brand name

GOPRELTO

Generic name

COCAINE HYDROCHLORIDE

Active ingredients

COCAINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

NASAL

Marketing status

Prescription

Sponsor

LXO IRELAND

Manufacturer

LXO US INC.

First approval

2017-12-14

Source

Authoritative

Drugs@FDA application overview

Machine

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