NDA 204915, held by Mylan Labs Ltd. Abacavir;Lamivudine.
As of Nov 14, 2026, NDA 204915 (Abacavir And Lamivudine), held by Mylan Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2014 | Original applicationNew dosage form · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abacavir And Lamivudine120MG;60MG · tablet; oral suspension | Abacavir;Lamivudine | None (tentative approval) |
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
