Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2021-09-13

FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Macleods Pharmaceuticals Limited)

View source ↗

Summary

FDA approved Macleods' generic fixed-dose tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate through an originalANDA.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (Efavirenz; Emtricitabine; Tenofovir disoproxil fumarate)

Snippet

ORIG AP for EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE)