Drug Approval Package: Tolsura

Company: Mayne Pharma International Pty Ltd
Application Number: 208901
Approval Date: 12/11/2018

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

• Chemistry Review(s) (PDF)
• Multi-Discipline Review (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Administrative & Correspondence Documents (PDF)

Date created: February 7, 2019

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