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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 090584

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NDA 090584 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Rising, Sagent Pharms, and Sandoz, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the FLUMAZENIL profile page.

The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for 090584

Tradename:	FLUMAZENIL
Applicant:	Sagent Pharms
Ingredient:	flumazenil
Patents:	0

Medical Subject Heading (MeSH) Categories for 090584

Antidotes
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5MG/5ML (0.1MG/ML)
Approval Date:	Aug 28, 2012	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/10ML (0.1MG/ML)
Approval Date:	Aug 28, 2012	TE:	AP	RLD:	No

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