Drug Approval Package: Seebri Neohaler (glycopyrrolate)
Company: Novartis Pharmaceuticals Corporation
Application No.: 207923Orig1
Approval Date: October 29, 2015
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- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative and Correspondence Document(s) (PDF)
Date created: December 6, 2016
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