Drug Approval Package
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Levothyroxine Sodium for Injection, 100 mcg, 200 mcg, and 500 mcg vials
Company: APP Pharmaceuticals, LLC
Application No.: 202231
Approval Date: 06/24/2011
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)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Microbiology Review (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: March 9, 2012
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