Drug Approval Package

 VisionBlue (Trypan Blue) Ophthalmic Solution
Company:  DORC International
Application No.:  021670
Approval Date: 12/16/2004

• Approval Letter(s) (PDF)

• Approvable Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 032005

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