Drug Approval Package: ORKAMBI (lumacaftor/ivacaftor)
Company: Vertex Pharmaceuticals
Application Number: 211358
Approval Date: 08/07/2018
Application Number: 211358
Approval Date: 08/07/2018
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Officer/Employee List (PDF)
- Multi-Discipline Review (PDF)
- Product Quality Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
Date created: February 7, 2019
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