Drug Approval Package: JELMYTO
Company: UroGen Pharma Ltd
Application Number: 211728
Approval Date: 04/15/2019
Application Number: 211728
Approval Date: 04/15/2019
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Product Quality Review(s) (PDF)
- Multi-Discipline Review (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
Date created: June 11, 2020
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