FDA Application
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Amiodarone
Hydrochloride Tablets
Company: Copley Pharmaceutical, Inc.
Application No.: 74-739
Approval Date: 11/30/1998
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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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Bioequivalence Review(s) (PDF)
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Correspondence (PDF)
Date created: November 20, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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