Drug Approval Package: GEMTESA
Company: Urovant Sciences GmbH
Application Number: 213006
Approval Date: 12/23/2020
Application Number: 213006
Approval Date: 12/23/2020
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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)
- Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
- Clinical Review(s) (PDF)
- Office Director Memo (PDF)
- Non-Clinical Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Statistical Review(s) (PDF)
- Summary Review (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: January 19, 2021
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