Drug Approval Package: TWIRLA
Company: Agile Therapeutics, Inc.
Application Number: 204017
Approval Date: 02/14/2020
Application Number: 204017
Approval Date: 02/14/2020
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 Pharmacology and Biopharmaceutics Review(s) (PDF)
- Clinical Review(s) (PDF)
- Cross Discipline Team Leader Review (PDF)
- Other Action Letters (PDF)
- Non-Clinical Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Statistical Review(s) (PDF)
- Summary Review (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: April 30, 2020
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®.