Drug Approval Package

 Doryx (Doxycycline Hyclate) Delayed-Release Tablets
Company:  F.H. Faulding and Co.
Application No.:  050795
Approval Date: 05/06/2005

• 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: April 212006

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