Drug Approval Package

 OraDisc (Amlexanox) Mucoadhesive Patch
Company:  Access Pharmaceuticals, Inc.
Application No.:  021727
Approval Date: 09/29/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 202006

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