Drug Approval Package: NUCALA (mepolizumab)
Company: GlaxoSmithKline LLC
Application Number: 761122
Approval Date: 06/06/2019
Application Number: 761122
Approval Date: 06/06/2019
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Chemistry Review(s) (PDF)
- Multi-Discipline Review (PDF)
- Propietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: August 26, 2019
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