Drug Approval Package
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Mexiletine Hydrochloride Capsules USP
Company: Danbury Pharmacal, Inc.
Application No.: ANDA 74-865
Approval Date: 4/13/98
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Approval Letter and Final Printed Labeling (PDF) (1.2 MB)
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Bioequivalence Review(s) (PDF) (1.4 MB)
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Administrative Documents and Correspondence (PDF) (904 KB)
Date created: June 23, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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