← FDA Drug Approvals (Drugs@FDA)

CAPLYTA

NDA · New Drug Application · Sponsor: INTRA-CELLULAR · Approved 2019-12-20

Drug application

FDA Application #

NDA209500

Application type

New Drug Application

Brand name

CAPLYTA

Generic name

LUMATEPERONE

Active ingredients

LUMATEPERONE TOSYLATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

INTRA-CELLULAR

Manufacturer

Intra-Cellular Therapies, Inc

First approval

2019-12-20

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown