Drug Approval Package
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Aciphex (Rabeprazole Sodium) Tablets
Company: Eisai Medical Research
Application No.: 020973/S-13, 021456
Approval Date: 11/8/2002
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
Part 1 (PDF)
Part 2 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created: April 25, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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