Viagra (sildenafil citrate)
Company: Pfizer
Application No.: 020895
Approval Date: 3/27/1998
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- FDA's Clinical, Statistical and Biopharmacological Review of Viagra Clinical Development
- Cover Sheet (PDF) (3/27/1998)
- Joint Clinical Reviews (3/27/1998)
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A. Table of Contents (PDF)
B. Sections 1-6 (PDF)
C. Section 7 (PDF)
D. Section 8 (PDF)
E. Section 9-10 (PDF)
F. Appendix A, Sections 1-4 (PDF)
G. Appendix A, Sections 5-9 (PDF)
H. Appendix A, Sections 10-13 (PDF)
I. Appendix A, Sections 14-22 (PDF)
J. Appendix A, Sections 23-33 (PDF)
K. Appendix A, Sections 34-43 (PDF)
L. Appendix A, Sections 44-51 (PDF)
M. Appendix A, Sections 52-56 (PDF)
- Chemistry Review (PDF) (3/27/1998)
- Pharmacology Reviews (3/27/1998)
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A. Review and Evaluation of Pharmacology and Toxicology Data, Pages 1-25 (PDF)
B. Review and Evaluation of Pharmacology and Toxicology Data, Pages 26-48 (PDF)
C. Review and Evaluation of Pharmacology and Toxicology Data, Pages 49-65 (PDF)
D. Review and Evaluation of Pharmacology and Toxicology Data, Pages 66-90 (PDF)
E. Review and Evaluation of Pharmacology and Toxicology Data, Pages 91-116 (PDF)
F. Review and Evaluation of Pharmacology and Toxicology Data, Pages 117-142 (PDF)
- Statistical Carcinogenicity Reviews (3/27/1998)
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A. Carcinogenicity Review of Sildenafil in Rats and Mice (PDF)
B. Appendix A, Male Rats (PDF)
C. Appendix B, Female Rats (PDF)
D. Appendix C, Male Mice (PDF)
E. Appendix D, Female Mice (PDF)
- Carcinogenicity Assessment Committee and FDA/CDER Rodent Carcinogenicity Database Factsheet (PDF) (3/27/1998)
- Administrative Documents (PDF) (3/27/1998)
- Correspondence (PDF) (3/27/1998)
Date created: March 27, 1998
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