Drug Approval Package
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Lupaneta Pack (leuprolide acetate for depot suspension and norethindrone acetate tablets) 3.75mg/5mg and 11.25mg/5mg
Company: Abbott Endocrine, Inc.
Application No.: 203696
Approval Date: 12/14/2012
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Statistical Review (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: September 9, 2013
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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