Drug Approval Package
Welchol (Colesevelarn Hydrochloride) Tablets and
Capsules
Company: GelTex Pharmaceuticals, Inc.
Application No.: 21-141 & 21-176
Approval Date: 5/26/2000
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Environmental Assessment (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
Date created: April 04, 2002
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