ANDA 206483, held by Orient Pharma Co Ltd. Glyburide.
As of Nov 14, 2026, ANDA 206483 (Glyburide), held by Orient Pharma Co Ltd, was first approved by FDA on Feb 22, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 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
