Drug Approval Package: Levothyroxine Sodium Injection
Company: Fresenius Kabi USA, LLC
Application Number: 210632Orig1s000
Approval Date: 04/11/2019
Application Number: 210632Orig1s000
Approval Date: 04/11/2019
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Clinical Pharmacology Review (PDF)
- Non-Clinical Review (PDF)
- Chemistry Review(s) (PDF)
- Other Review(s) (PDF)
Date created: December 17, 2019
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