ANDA 78595, held by Rising. Flumazenil.
As of Nov 15, 2026, ANDA 78595 (Flumazenil), held by Rising, was first approved by FDA on May 13, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2008 | Original application | Approved | None posted |
| Flumazenil0.5MG/5ML (0.1MG/ML) · injectable;injection | Flumazenil | Rx |
| Flumazenil1MG/10ML (0.1MG/ML) · injectable;injection | Flumazenil | Discontinued |
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
