ANDA 212552, held by Fresenius Kabi USA. Liraglutide.
As of Nov 15, 2026, ANDA 212552 (Liraglutide), held by Fresenius Kabi USA, was first approved by FDA on Mar 30, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 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
