Drug Approval Package: SoluPrep
Company: 3M Health Care
Application Number: 208288
Approval Date: 08/18/2018
Application Number: 208288
Approval Date: 08/18/2018
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
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Clinical Review(s) (PDF)
- Clinical Microbioloogy/Virology Review(s) (PDF)
- Product Quality Review(s) (PDF)
- Non-Clincial Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Other Action Letters (PDF)
- Administrative & Correspondence Document(s) (PDF)
Date created: February 7, 2019
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