Drug Approval Package
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NeoProfen (Ibuprofen Lysine) Injection
Company: Farmacon-IL, LLC
Application No.: 021903
Approval Date: 04/13/2006
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Approval Letter(s) (PDF)
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Approvable Letter (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
Date created: April 22, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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