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Macrilen (macimorelin) for Oral Solution

Macrilen

Company: Aeterna Zentaris, Inc.
Application No.: 205598
Approval Date: 12/20/2017

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

Approval Letter(s) (PDF)
Other Action Letters (PDF)
Printed Labeling (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)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: January 31, 2018

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