You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 18, 2025

Details for New Drug Application (NDA): 090316


✉ Email this page to a colleague

« Back to Dashboard


NDA 090316 describes MIDOZALAM HYDROCHLORIDE, which is a drug marketed by Onesource Specialty and is included in one NDA. It is available from two suppliers. Additional details are available on the MIDOZALAM HYDROCHLORIDE profile page.

The generic ingredient in MIDOZALAM 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 090316
Tradename:MIDOZALAM HYDROCHLORIDE
Applicant:Onesource Specialty
Ingredient:midazolam hydrochloride
Patents:0
Pharmacology for NDA: 090316
Medical Subject Heading (MeSH) Categories for 090316
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives
Suppliers and Packaging for NDA: 090316
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDOZALAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 090316 ANDA SOMERSET THERAPEUTICS, LLC 70069-818 70069-818-10 10 VIAL in 1 CARTON (70069-818-10) / 10 mL in 1 VIAL
MIDOZALAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 090316 ANDA Steriscience Specialties Private Limited 82449-207 82449-207-02 10 VIAL in 1 CARTON (82449-207-02) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:May 4, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:May 4, 2011TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.

 
© Copyright 2002-2025 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2025 - 2026
 NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links