Drug Approval Package

Makena (hydroxyprogesterone caproate) injection, 250 mg/ml
Company: Hologic, Inc.
Application No.: 021945
Approval Date: 02/03/2011

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

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

Date created: October 31, 2012

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®.