For type 2 diabetes mellitus. ANDA 215421, held by Lupin. Liraglutide.
As of Nov 15, 2026, ANDA 215421 (Liraglutide), held by Lupin, was first approved by FDA on Jul 22, 2025, with 0 approved supplements and 0 published complete response letters.
Liraglutide injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus Limitations of Use: Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Liraglutide18MG/3ML (6MG/ML) · 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
