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Accenture
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Healthtrust
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Chinese Patent Office
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203460

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NDA 203460 describes MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa, Hospira, and Mylan Asi, and is included in three NDAs. It is available from five suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 203460
Tradename:MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:midazolam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203460
Ingredient-typeBenzodiazepines
Suppliers and Packaging for NDA: 203460
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE midazolam hydrochloride INJECTABLE;INJECTION 203460 ANDA Fresenius Kabi USA, LLC 76045-001 N 76045-001-20
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE midazolam hydrochloride INJECTABLE;INJECTION 203460 ANDA Fresenius Kabi USA, LLC 76045-002 N 76045-002-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Aug 22, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Aug 22, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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