For type 2 diabetes mellitus. ANDA 203379, held by Cadila Pharms Ltd. Glyburide.
As of Nov 14, 2026, ANDA 203379 (Glyburide), held by Cadila Pharms Ltd, was first approved by FDA on Jan 4, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 2019 | 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
