FDA Application
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Ibuprofen and
Pseudoephedrine Hydrochloride
Company: Pharmaceutical Formulations
Application No.: 075588
Approval Date: 04/08/2002
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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: December 23, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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