Drug Approval Package: KATERZIA
Company: Silvergate Pharmaceuticals, Inc.
Application Number: 211340
Approval Date: 07/08/2019
Application Number: 211340
Approval Date: 07/08/2019
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Product Quality Review(s) (PDF)
- Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Summary Review (PDF)
Date created: January 16, 2020
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
Note: Documents in PDF format require the Adobe Acrobat Reader®.