← FDA Drug Approvals (Drugs@FDA)

ORGOVYX

NDA · New Drug Application · Sponsor: SUMITOMO PHARMA AM · Approved 2020-12-18

Drug application

FDA Application #

NDA214621

Application type

New Drug Application

Brand name

ORGOVYX

Generic name

RELUGOLIX

Active ingredients

RELUGOLIX

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

SUMITOMO PHARMA AM

Manufacturer

Sumitomo Pharma America, Inc.

First approval

2020-12-18

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown