← FDA Drug Approvals (Drugs@FDA)

RAYALDEE

NDA · New Drug Application · Sponsor: EIRGEN · Approved 2016-06-17

Drug application

FDA Application #

NDA208010

Application type

New Drug Application

Brand name

RAYALDEE

Generic name

CALCIFEDIOL

Active ingredients

CALCIFEDIOL

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

EIRGEN

Manufacturer

OPKO Pharmaceuticals LLC

First approval

2016-06-17

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown