Drug Approval Package: Teglutik (riluzole)
Company: DJA Global Pharmaceuticals, Inc.
Application Number: 209080
Approval Date: 00/00/2019
Application Number: 209080
Approval Date: 00/00/2019
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Clinical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Non-Clinical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Properitary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: February 7, 2019
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