Drug Approval Package: Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate)
Company: Mylan Pharmaceuticals, Inc.
Application Number: 208255
Approval Date: 02/05/2018
Application Number: 208255
Approval Date: 02/05/2018
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Other Action Letters (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: October 9, 2018
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