Drug Approval Package
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Argatroban Injection, 250 mg/250 mL
Company: Teva Pharmaceuticals USA
Application No.: 206769Orig1s000
Approval Date: 12/15/2014
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: January 27, 2015
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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