(contact us for more information on Ionsys)
Brand NameIonsys
Generic Namefentanyl PCA
Marketed byOrtho-McNeil-Janssen Pharmaceuticals, Inc.
NDA/BLA HolderAlza
NDA/BLA NumberNDA 21-338
NDA/BLA Approval Date5/22/2006
StatusApproved - Not Available in U.S. Market
Review ClassificationStandard
REMS Approval Date3/25/2009
Class REMSNo
REMS Source Document
Boxed Warning?
Boxed Warning
Route of Administration
Mechanism of Action
Risks (MedGuide Language)
Approved Labeling
Medication Guide?
Medication Guide
Medication Guide Version
Communication Plan?
Communication Plan
Elements to Assure Safe Use?
Elements to Assure Safe Use
Implementation System?
Implementation System
Assessment Program
Assessment Program Timeline
Branded Program
Program Description
Link to Branded Program
Approval Letters


REMS Document: from FDA Approved REMS

Approval Letters: from FDA Medication Guide Website

Approved Labeling: from FDA Medication Guide Website

Medication Guide: from FDA Medication Guide Website

Previous page: REMS Directory Next page: REMS White Papers
Register for periodic industry updates:

2018© 2015 ParagonRx. All rights reserved.