Details for New Drug Application (NDA): 208878

NDA 208878 describes MIDAZOLAM HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Endo Operations, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Rising, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, Rafa Labs Ltd, and Steriscience Speclts, and is included in thirty-six NDAs. It is available from twenty 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-five 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

Pharmacology for NDA: 208878

Medical Subject Heading (MeSH) Categories for 208878

Adjuvants, Anesthesia

Anesthetics, Intravenous

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Suppliers and Packaging for NDA: 208878

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	208878	ANDA	Fresenius Kabi USA, LLC	63323-412	63323-412-02	10 VIAL in 1 TRAY (63323-412-02) / 2 mL in 1 VIAL (63323-412-03)
MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	208878	ANDA	Fresenius Kabi USA, LLC	63323-412	63323-412-10	10 VIAL in 1 TRAY (63323-412-10) / 10 mL in 1 VIAL (63323-412-13)

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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