Proquin XR Extended-Release Tablets

(contact us for more information on Proquin XR Extended-Release Tablets)
Brand NameProquin XR Extended-Release Tablets
Generic Nameciprofloxacin
Marketed byDepomed Inc.
NDA/BLA HolderDepomed Inc
NDA/BLA NumberNDA 21-744/S-012
NDA/BLA Approval Date5/19/2005
Review ClassificationStandard
REMS Approval Date4/27/2009
Class REMSFluoroquinolone Antibiotic
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.