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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077071

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NDA 077071 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 077071

Tradename:	FLUMAZENIL
Applicant:	Sandoz
Ingredient:	flumazenil
Patents:	0

Medical Subject Heading (MeSH) Categories for 077071

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:	May 3, 2005	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:	May 3, 2005	TE:	AP	RLD:	No

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