Palonosetron Hydrochloride (HCl) Injection
Company: Dr. Reddy’s Laboratories Limited
Application No.: 203050
Approval Date: 03/01/2016
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- Approval Letter(s) (PDF)
- Other Action Letters (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)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: December 13, 2016
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