Drug Approval Package: HERCEPTIN HYLECTA
Company: Genentech, Inc.
Application Number: 761106
Approval Date: 02/28/2019
Application Number: 761106
Approval Date: 02/28/2019
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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)
- Multi-Discipline Review (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: October 17, 2019
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