Drug Approval Package: ABLYSINOL

Company: Belcher Pharmaceuticals, LLC
Application Number: 207987
Approval Date: 06/21/2018

Drugs@FDA information available about Hydrocodone

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 Pharmocolgy and Biopharmaceutics Reveiw(s) (PDF)
• Clinical Review(s) (PDF)
• Propietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Action Letters (PDF)
• Other Review(s) (PDF)
• Non-Clinical Review(s) (PDF)
• Statistical Review(s) (PDF)
• Summary Review (PDF)

Date created: February 7, 2019

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