NDA 215040, held by Galephar. Acetylcysteine Lysine.
As of Nov 14, 2026, NDA 215040 (Legubeti), held by Galephar, was first approved by FDA on Feb 13, 2024, with 0 approved supplements and 1 published complete response letter.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2024 | Original applicationTYPE 2/3 · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| May 5, 2023 | Legubeti (acetylcysteine)Clinical | Approved |
| LegubetiEQ 500MG BASE/PACKET · for solution;oral | Acetylcysteine Lysine | DiscontinuedReference drug |
| LegubetiEQ 2.5GM BASE/PACKET · for solution;oral | Acetylcysteine Lysine | 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
