Details for New Drug Application (NDA): 018654

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NDA 018654 describes VERSED, which is a drug marketed by HLR and Roche and is included in two NDAs. Additional details are available on the VERSED profile page.

The generic ingredient in VERSED is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for 018654

Tradename:	VERSED
Applicant:	Hlr
Ingredient:	midazolam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 018654

Adjuvants, Anesthesia
Anesthetics, Intravenous
Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1985	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 26, 1987	TE:		RLD:	Yes

Expired US Patents for NDA 018654

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987	⤷ Sign Up	⤷ Sign Up
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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