← FDA Drug Approvals (Drugs@FDA)

ARTHROTEC

NDA · New Drug Application · Sponsor: PFIZER · Approved 1997-12-24

Drug application

FDA Application #

NDA020607

Application type

New Drug Application

Brand name

ARTHROTEC

Generic name

DICLOFENAC SODIUM AND MISOPROSTOL

Active ingredients

DICLOFENAC SODIUM; MISOPROSTOL

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

PFIZER

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

1997-12-24

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown