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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 075873

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NDA 075873 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 seventeen 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-two suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for 075873

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

Pharmacology for NDA: 075873

Medical Subject Heading (MeSH) Categories for 075873

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

Suppliers and Packaging for NDA: 075873

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	075873	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3566	0054-3566-99	118 mL in 1 BOTTLE, GLASS (0054-3566-99)
MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	075873	ANDA	American Health Packaging	60687-576	60687-576-10	3 TRAY in 1 CASE (60687-576-10) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-04) / 2.5 mL in 1 CUP, UNIT-DOSE (60687-576-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	EQ 2MG BASE/ML
Approval Date:	Apr 30, 2002	TE:	AA	RLD:	No

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