Drug Approval Package

 Omnicef (Cefdinir) Capsules & Oral Suspension
Company:  Parke-Davis
Application No.:  050739 & 050749
Approval Date: 12/04/1997

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical & Statistical Review(s) (PDF)

• Chemistry Review(s) (PDF)    

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)    

• Microbiology Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s) & Correspondence (PDF)  

Date created: October 3, 2006

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