NDA 204311, held by Pharmobedient. Abacavir Sulfate; Lamivudine.
As of Nov 14, 2026, NDA 204311 (Abacavir Sulfate And Lamivudine), held by Pharmobedient, was first approved by FDA on Dec 22, 2023, with 0 approved supplements and 2 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Jan 13, 2023 | NDA 204311Facility Inspections | Approved |
| Aug 6, 2019 | NDA 204311Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abacavir Sulfate And LamivudineEQ 60MG BASE;30MG · tablet, for suspension;oral | Abacavir Sulfate; Lamivudine | 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
