ANDA 213155, held by Mylan Institutional. Liraglutide.
As of Nov 15, 2026, ANDA 213155 (Liraglutide), held by Mylan Institutional, was first approved by FDA on Jun 15, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Liraglutide18MG/3ML (6MG/ML) ยท solution;subcutaneous | Liraglutide | Rx |
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