Drug Approval Package: GLYCOPYRROLATE
Company: Fresenius Kabi USA, LLC
Application Number: 214919
Approval Date: 4/21/2022
Application Number: 214919
Approval Date: 4/21/2022
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Product Quality Review(s) (PDF)
- Non-Clinical Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- Summary Review (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: October 14, 2022
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