Drug Approval Package

 Prevacid Solutab Delayed-Release Orally Disintegrating Tablets, Capsules & Oral Suspension
Company:  TAP Pharmaceutical Products
Application No.:  021428, 020406s052 & 021281s007
Approval Date: 8/30/2002

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)  

• Chemistry Review(s) (PDF)

• Microbiology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)  

Date created: June 232005

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