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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075247

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NDA 075247 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 075247

Tradename:	MIDAZOLAM HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	midazolam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 075247

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Jun 23, 2000	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Jun 23, 2000	TE:	AP	RLD:	No

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