ANDA 75947, held by Actavis Elizabeth. Glyburide.
As of Nov 14, 2026, ANDA 75947 (Glyburide), held by Actavis Elizabeth, was first approved by FDA on Nov 14, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2002 | 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
