For type 2 diabetes mellitus. ANDA 205980, held by Mylan. Saxagliptin Hydrochloride.
As of Nov 15, 2026, ANDA 205980 (Saxagliptin), held by Mylan, was first approved by FDA on Jul 31, 2023, with 0 approved supplements and 0 published complete response letters.
Saxagliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2023 | Original application | Approved |
| SaxagliptinEQ 2.5MG BASE · tablet;oral | Saxagliptin Hydrochloride | Rx |
| SaxagliptinEQ 5MG BASE · tablet;oral | Saxagliptin Hydrochloride | 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
