Drug Approval Package
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Nolvadex (Tamoxifen Citrate) Tablets
Company: Zeneca Pharmaceuticals
Application No.: 17-970/S039/S040
Approval Date: 10/29/1998
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Approval Letter (PDF)
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Medical Review(s)
Part 1 (PDF) (2.2 MB) Part 6 (PDF) (2.6 MB) Part 11 (PDF) (2.6 MB) Part 2 (PDF) (2.4 MB) Part 7 (PDF) (2.6 MB) Part 12 (PDF) (2.6 MB) Part 3 (PDF) (2.2 MB) Part 8 (PDF) (2.6 MB) Part 13 (PDF) (2.6 MB) Part 4 (PDF) (2.9 MB) Part 9 (PDF) (2.9 MB) Part 14 (PDF) (2.7 MB) Part 5 (PDF) (2.6 MB) Part 10 (PDF) (2.5 MB) -
Chemistry Review(s) & Statistical Review(s) (PDF) (PDF) (1.4 MB)
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Administrative Document(s)
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (2.7 MB) -
Correspondence (PDF) (361 KB)
Date created: March 30, 2001; last update: July 5, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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