Giapreza (angiotensin II) 2.5 mg/mL Injection
Company: La Jolla Pharmaceutical Company
Application No.: 209360
Approval Date: 12/21/2017
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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)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (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: January 31, 2018
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