NDA 22344, held by Aurobindo Pharma Ltd. Lamivudine; Tenofovir Disoproxil Fumarate.
As of Nov 13, 2026, NDA 22344 (Lamivudine And Tenofovir Disoproxil Fumarate), held by Aurobindo Pharma Ltd, was first approved by FDA on May 15, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine And Tenofovir Disoproxil Fumarate300MG;300MG · tablet;oral | Lamivudine; Tenofovir Disoproxil Fumarate | DiscontinuedReference drug |
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
