Drug Approval Package

Orapred ODT (Prednisolone Sodium Phosphate) Orally Disintegrating Tablets
Company: BioMarin Pharmaceutical Inc.
Application No.:  021959
Approval Date: 06/02/2006

• Approval Letter(s) (PDF) 

• Proprietary Name Review(s) (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) (PDF) 

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: July 8, 2008

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.