Flumazenil

ANDA 90584, held by Sagent Pharms. Flumazenil.

As of Nov 15, 2026, ANDA 90584 (Flumazenil), held by Sagent Pharms, was first approved by FDA on Aug 28, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 28, 2012
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 28, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Flumazenil0.5MG/5ML (0.1MG/ML) · injectable;injection	Flumazenil	Rx
Flumazenil1MG/10ML (0.1MG/ML) · injectable;injection	Flumazenil	Rx

All 2 submissions, including labeling and manufacturing supplements


May 1, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Aug 28, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 90584
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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