Drug Approval Package: Jornay PM (methylphenidate hydrochloride)

Company: Ironshore Pharmaceuticals & Development, Inc.
Application Number: 209311
Approval Date: 08/08/2018

Drugs@FDA information available about Jornay PM

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Other Action Letters (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical 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: January 28, 2019

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