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Patient Information Sheet [PDF]
[HTML]
(7/8/2005)
Professional Information Sheet [PDF]
[HTML] (7/8/2005)
FDA
Statement (7/8/2005)
Label
(7/8/2005)
Background Information
The FDA approved Viagra on March 27, 1998. Viagra is
the first oral pill to treat impotence, a dysfunction that affects millions
of men in the United States. Viagra is manufactured by Pfizer
Pharmaceuticals, New York, NY.
Revised Viagra Label
(9/19/2004)
FDA Talk Paper--Pfizer Updates Viagra Labeling (11/24/1998)
New Viagra Prescribing Information
(11/24/1998)
FDA
Labeling Supplement Approval Letter
(11/24/1998)
Revised
Viagra Label
(11/24/1998)
Dear Health Professional Letter About Viagra (Safety Notice) (5/1998)
FDA buy viagra Talk Paper on Viagra Approval (3/27/1998)
Viagra
Approval Letter
(3/27/1998)
Questions and Answers about Viagra (3/27/1998)
Amendment
to Clinical Review of 22 January 1998: Effects of Sildenafil on the Electroretinogram in
Study 148-232 (5/13/1998)
FDA's buy viagra Clinical, Statistical and Biopharmacological Review of Viagra
Clinical Development
Cover
Sheet
(3/27/1998)
Joint Clinical Reviews (3/27/1998)
A. Table
of Contents
B. Sections
1-6
C. Section 7
D. Section 8
E. Section
9-10
F. Appendix
A, Sections 1-4
G. Appendix
A, Sections 5-9
H. Appendix
A, Sections 10-13
I. buy viagra Appendix
A, Sections 14-22
J. Appendix
A, Sections 23-33
K. Appendix
A, buy viagra Secti
|
|
ons 34-43
L. Appendix
A, Sections 44-51
M. Appendix
A, Sections 52-56 buy viagra
Chemistry
Review
(3/27/1998)
Pharmacology Reviews (3/27/1998)
A. Review and
Evaluation of Pharmacology and buy viagra Toxicology Data, Pages 1-25
B. Review
and Evaluation of Pharmacology and Toxicology Data, Pages 26-48
C. Review
and Evaluation of Pharmacology and Toxicology Data, Pages 49-65
D. Review
and Evaluation of Pharmacology and buy viagra Toxicology Data, Pages 66-90
E. Review
and Evaluation of Pharmacology buy viagra and Toxicology Data, Pages 91-116 buy viagra
F. Review
and buy viagra Evaluation of Pharmacology and Toxicology Data, Pages 117-142
Statistical buy viagra Carcinogenicity Reviews (3/27/1998)
A. Carcinogenicity
Review of Sildenafil in Rats and buy viagra Mice
B. buy viagra Appendix A, Male
Rats buy viagra
C. Appendix B,
Female Rats
D. Appendix C, Male
Mice
E. Appendix D,
Female Mice
Carcinogenicity
Assessment Committee and buy viagra FDA/CDER Rodent Carcinogenicity Database Factsheet
(3/27/1998)
Administrative
Documents
(3/27/1998)
Correspondence
(3/27/1998)
Some of these documents are in Portable Document
Format (PDF) to retain the original format. To view or print these
documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly
from Adobe's website with full installation buy viagra instructions.
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Date created: July 8, 2005
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Patient Information Sheet for Viagra
Please click on the
following link to open the updated Patient Information sheet.
http://www.fda.gov/cder/drug/InfoSheets/patient/sildenafilPIS.htm
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