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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076058

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NDA 076058 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 nineteen 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-four suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for 076058

Tradename:	MIDAZOLAM HYDROCHLORIDE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	midazolam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 076058

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
Approval Date:	Mar 15, 2002	TE:		RLD:	No

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