ANDA 75040, held by Esi Lederle. Propofol.
As of Nov 14, 2026, ANDA 75040 (Propofol), held by Esi Lederle, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 24, 1999 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propofol10MG/ML ยท injectable; injection | Propofol | None (tentative approval) |
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