Drug Approval Package: APADAZ
Company: KemPharm, Inc.
Application Number: 208653
Approval Date: 02/23/2018
Application Number: 208653
Approval Date: 02/23/2018
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- REMS (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: February 27, 2019
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