ANDA 206078, held by Sun Pharm. Saxagliptin Hydrochloride.
As of Nov 15, 2026, ANDA 206078 (Saxagliptin), held by Sun Pharm, was first approved by FDA on Jul 31, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2023 | Original application | Approved |
| SaxagliptinEQ 2.5MG BASE · tablet;oral | Saxagliptin Hydrochloride | Discontinued |
| SaxagliptinEQ 5MG BASE · tablet;oral | Saxagliptin Hydrochloride | Discontinued |
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
