Sucraid Oral Solution

(contact us for more information on Sucraid Oral Solution)
Brand NameSucraid Oral Solution
Generic Namesacrosidase
Marketed byOrphan Medical Inc.
NDA/BLA HolderQOL Medical
NDA/BLA NumberNDA 20-772/S-005
NDA/BLA Approval Date4/9/1998
Review ClassificationPriority, Orphan
REMS Approval Date11/20/2008
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.