Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Johnson and Johnson
Queensland Health
Express Scripts
Harvard Business School

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203460

« Back to Dashboard

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 six 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-three suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 203460
Applicant:Fresenius Kabi Usa
Ingredient:midazolam hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 203460
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.