Drug Approval Package
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Venlafaxine Hydrochloride Extended Release 37.5 mg, 75 mg, 150 mg, and 225 mg Tablets
Company: Osmotica Pharmaceutical Corp.
Application No.: 022104
Approval Date: 5/20/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Approvable Letter (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: July 29, 2009
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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