Details for New Drug Application (NDA): 020942

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NDA 020942 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-four suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for 020942

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

Medical Subject Heading (MeSH) Categories for 020942

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 15, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020942

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998	4,280,957*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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