Drug Approval Package: Efavirenz, Lamivudine and Tenofovir disoproxil
Company: Aurobindo Pharma USA, Inc.
Application Number: 022343
Approval Date: 08/15/2018
Application Number: 022343
Approval Date: 08/15/2018
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Other Action Letters (PDF)
- Officer/Employee List (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Other Review(s) (PDF)
Date created: November 26, 2018
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