← FDA Drug Approvals (Drugs@FDA)

CEVIMELINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2013-07-08

Drug application

FDA Application #

ANDA091591

Application type

Abbreviated New Drug Application (Generic)

Brand name

CEVIMELINE HYDROCHLORIDE

Generic name

CEVIMELINE HYDROCHLORIDE

Active ingredients

CEVIMELINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2013-07-08

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown