Drug Approval Package: Tetracaine Hydrochloride Ophthalmic Solution
Company: Paragon BioTeck Inc.
Application Number: 210821
Approval Date: 03/12/2019
Application Number: 210821
Approval Date: 03/12/2019
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
- Officer/Employee List (PDF)
- Other Action Letters (PDF)
- Multi Discipline Review (PDF)
- Product Quality Review(s) (PDF)
- Other Review(s) (PDF)
Date created: February 7, 2019
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