An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drug Approval Package: Qbrelis (lisinopril)

Company: Silvergate Pharmaceuticals, Inc.
Application No.: 208401Orig1
Approval Date: July 29, 2016

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Cross Discipline Team Leader Review (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: December 21, 2016

Back to Top Drugs@FDA

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®.

Top