Drug Approval Package

 Acetadote (Acetylcysteine) Injection
Company:  Cumberland Pharmaceuticals, Inc.
Application No.:  021539
Approval Date: 1/23/2004

• 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) (PDF)  

Date created: October 182004

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