Last Updated: June 24, 2026

Details for New Drug Application (NDA): 208878

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NDA 208878 describes MIDAZOLAM HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Ph Health, Rising, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, Rafa Labs Ltd, and Onesource Specialty, and is included in thirty-six NDAs. It is available from sixteen suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE profile page.

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

Summary for 208878

Tradename:	MIDAZOLAM HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	midazolam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 208878

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
Approval Date:	Mar 28, 2017	TE:		RLD:	No

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