Manages benzodiazepine overdose. ANDA 76955, held by Fresenius Kabi USA. Flumazenil.
As of Nov 15, 2026, ANDA 76955 (Flumazenil), held by Fresenius Kabi USA, was first approved by FDA on Oct 12, 2004, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. Pediatric Patients (aged 1 to 17) Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS, Pediatric Use ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 12, 2004 | Original application | Approved | None posted |
| Flumazenil1MG/10ML (0.1MG/ML) · injectable;injection | Flumazenil | Rx |
| Flumazenil0.5MG/5ML (0.1MG/ML) · injectable;injection | Flumazenil | Rx |
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
