ANDA 206079, held by Impax Labs Inc. Glyburide.
As of Nov 14, 2026, ANDA 206079 (Glyburide), held by Impax Labs Inc, was first approved by FDA on Sep 30, 2015, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 2015 | Original application | Approved | None posted |
| Sep 7, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 30, 2015 | 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
