VANTRELA ER (hydrocodone bitartrate) Extended-Release Tablets
Company: Teva Branded Pharmaceutical Products R & D, Inc.
Application No.: 207975
Approval Date: 01/17/2017
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- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- REMS (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)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: March 16, 2017
Updated March 28,2017
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