Drug Approval Package: TRALEMENT
Company: American Regent, Inc.
Application Number: 209376
Approval Date: 7/2/2020
Application Number: 209376
Approval Date: 7/2/2020
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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)
- Multi-Discipline Review (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: February 22, 2021
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