For type 2 diabetes mellitus. ANDA 206749, held by Zydus Pharms. Glyburide.
As of Nov 14, 2026, ANDA 206749 (Glyburide), held by Zydus Pharms, was first approved by FDA on May 10, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Glyburide tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2016 | Original application | Approved | None posted |
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
