Drug Approval Package
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Actonel
(Risedronate Sodium) Tablets
Company: Procter and Gamble Pharmaceuticals
Application No.: 20-835/S1, S2, S3 & S4
Approval Date: 4/14/00
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Approval Letter(s)(PDF)
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Printed Labeling(PDF)
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Medical Review(s)
Part 1(PDF) Part 2(PDF) Part 3(PDF) -
Chemistry Review(s)(PDF)
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Pharmacology Review(s)
Part 1(PDF) Part 2(PDF)
Date created: August 17, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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