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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020073

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NDA 020073 describes ROMAZICON, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ROMAZICON profile page.

The generic ingredient in ROMAZICON 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 020073

Tradename:	ROMAZICON
Applicant:	Hoffmann La Roche
Ingredient:	flumazenil
Patents:	0

Medical Subject Heading (MeSH) Categories for 020073

Antidotes
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/10ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1991	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1991	TE:		RLD:	Yes

Expired US Patents for NDA 020073

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-001	Dec 20, 1991	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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