Drug Approval Package
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Ultracet
(325 mg Acetaminophen/37.5 mg Tramadol Hydrochloride) Tablets
Company: R. W. Johnson Pharmaceutical Research Institute
Application No.: 21-123
Approval Date: 8/15/2001
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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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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
Date created: October 12, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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