Drug Approval Package
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Caldolor (Ibuprofen) Injection 400 mg/4 mL and 800 mg/8 mL
Company: Cumberland Pharmaceuticals
Application No.: 022348
Approval Date: 6/11/2009
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)
- Cross Discipline Team Leader Review (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)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: March 11, 2010
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