Veltassa (Patiromer) Powder for Oral Suspension
Company: Relypsa, Inc.
Application No.: 205739
Approval Date: 10/21/2015
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- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Office Director Memo (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Enviornmental Assessment(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: November 25, 2015
Updated: June 2, 2017
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