Drug Approval Package: EXSERVAN
Company: Aquestive Therapeutics
Application Number: 212640
Approval Date: 11/22/2019
Application Number: 212640
Approval Date: 11/22/2019
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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)
- Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
- Clinical Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Summary Review (PDF)
Date created: April 17, 2020
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