ANDA 76589, held by Dr Reddys. Flumazenil.
As of Nov 15, 2026, ANDA 76589 (Flumazenil), held by Dr Reddys, was first approved by FDA on Oct 12, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 12, 2004 | Original application | Approved | None posted |
| Flumazenil1MG/10ML (0.1MG/ML) · injectable;injection | Flumazenil | Discontinued |
| Flumazenil0.5MG/5ML (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
