FDA Application
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Diltiazem Hydrochloride Extended-Release Capsules USP
Company: Mylan Pharmaceuticals, Inc.
Application No.: ANDA 75-124
Approval Date: 3/18/98
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Approval Letter, Final Printed Labeling, and Chemistry Review(s) (PDF) (1.4 MB)
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Bioequivalence Review(s) (PDF) (2.6 MB)
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Administrative Documents and Correspondence (PDF) (1.6 MB)
Last update: June 30, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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