Drug Approval Package
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Calomist (cyanocobalamin, USP) Nasal Spray, 25 mcg/0.1 mL
Company: Fleming & Co., Pharmaceuticals
NDA: 022102
Approval Date: 7/27/2007
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Environmental Assessment (PDF)
- Pharmacology Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
Date created: April 14, 2009
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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