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Vaccines, Blood & Biologics
Approval History, Letters, Reviews, and Related Documents - AFLURIA
Proper Name: Influenza Virus Vaccine
Tradename: AFLURIA
Manufacturer: CSL Limited, License No. 1764
STN: 125254/0
Approval Date: September 28, 2007
Approval information/letter/labeling
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Memorandum/Reviews
- Midpoint Management Meeting Memorandum
- Review of Chemical Analytical Procedures
- Statistical Review
- Summary of Bioresearch Monitoring Inspections
- Committee Meeting Memorandum
- CMC Review
- Statistical Review and Evaluation-AFLURIA
- Clinical Review-AFLURIA (PDF - 2307KB)
- BLA Review Memo: Mycoplasma Testing
- Chair Memo
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Correspondence
- Telecon Memo - 8/31/2007 - AFLURIA
- Telecon Memo - 8/29/2007 - AFLURIA
- Telephone Conference Memorandum - 8/20/2007 - AFLURIA
- Telephone Conference Memorandum - 8/9/2007 - AFLURIA
- Telephone Conference Memorandum - 8/3/2007 - AFLURIA
- Telephone Conference Memorandum - 6/29/2007 - AFLURIA
- Telephone Conference Memorandum - 6/13/2007 - AFLURIA
- Telephone Conference Memorandum - 5/2/2007 - AFLURIA
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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