`
`http://www.accessdata.fda.gov/drugsatfda_docs/NDA/98/viagra/viagra_t...
`
`FDA Home3 Drugs4 Drug Approvals and Databases5 Drugs@FDA6
`Drug Approval Package
`
`Viagra (sildenafil citrate)
`Company: Pfizer
`Application No.: 020895
`Approval Date: 3/27/1998
`Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for
`assistance.
`FDA's Clinical, Statistical and Biopharmacological Review of Viagra Clinical Development
`1.
`Cover Sheet (PDF) (3/27/1998)
`
`
`Joint Clinical Reviews (3/27/1998)2.
`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)
`
`3.
`
`Chemistry Review (PDF) (3/27/1998)
`
`4.
`
`Pharmacology Reviews (3/27/1998)
`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)5.
`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 Factsheet6.
`(PDF) (3/27/1998)
`
`7.
`
`Administrative Documents (PDF) (3/27/1998)
`
`8.
`
`Correspondence (PDF) (3/27/1998)
`
`Date created: March 27, 1998
`
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` DRL - EXHIBIT 1031
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`
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`Drug Approval Package: Brand Name (Generic Name) NDA #
`
`http://www.accessdata.fda.gov/drugsatfda_docs/NDA/98/viagra/viagra_t...
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