Drug Approval Package

 Neuontin (Gabapentin) Tablets, Capsules & Oral Solution
Company:  Parke-Davis Pharmaceutical
Application No.:  021397, 021423 & 021424
Approval Date: 5/24/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: May 062004

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