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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078595

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NDA 078595 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 eight 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. Eight suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for 078595

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

Medical Subject Heading (MeSH) Categories for 078595

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 13, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/10ML (0.1MG/ML)
Approval Date:	May 13, 2008	TE:		RLD:	No

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