Drug Approval Package: Tigecycline
Company: Amneal Pharmaceuticals, LLC
Application Number: 211158
Approval Date: 08/02/2018
Application Number: 211158
Approval Date: 08/02/2018
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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)
- 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)
Date created: November 7, 2018
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