Drug Approval Package
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Cetirizine Hydrochloride Capsules, 5 mg and 10 mg
Company: Banner Pharmacaps, Inc.
Application No.: 022429
Approval Date: 7/23/2009
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence
Date created: December 15, 2009
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