Drug Approval Package

 Niravam (Alprazolam) Orally Disintegrating Tablets
Company:  Schwarz Pharma, Inc.
Application No.:  021726
Approval Date: 01/19/2005

• Approval Letter(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 252006

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