← FDA Drug Approvals (Drugs@FDA)

BRISDELLE

NDA · New Drug Application · Sponsor: LEGACY PHARMA · Approved 2013-06-28

Drug application

FDA Application #

NDA204516

Application type

New Drug Application

Brand name

BRISDELLE

Generic name

PAROXETINE

Active ingredients

PAROXETINE MESYLATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

LEGACY PHARMA

Manufacturer

Padagis US LLC

First approval

2013-06-28

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown