Symfi Lo

NDA 208255, held by Mylan. Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate.

As of Nov 13, 2026, NDA 208255 (Symfi Lo), held by Mylan, was first approved by FDA on Feb 5, 2018, with 1 approved supplement and 0 published complete response letters.

• First approved: Feb 5, 2018
• Review: Priority
• Supplements approved: 1
• Complete response letters: 0

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters