Drug Approval Package: SEMGLEE
Company: Mylan Pharmaceuticals Inc.
Application Number: 210605
Approval Date: 06/11/2020
Application Number: 210605
Approval Date: 06/11/2020
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Product Quality Review(s) (PDF)
- Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
- Clinical Review(s) (PDF)
- Other Action Letters (PDF)
- Non-Clinical Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Summary Review (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: December 21, 2020
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