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Queensland Health
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Generated: October 21, 2017

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Midazolam hydrochloride - Generic Drug Details

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What are the generic sources for midazolam hydrochloride and what is the scope of midazolam hydrochloride freedom to operate?

Midazolam hydrochloride
is the generic ingredient in four branded drugs marketed by Hospira Inc, Wockhardt, Sagent Agila Llc, Apotex Inc, Sagent Strides, Apothecon, Intl Medication, West-ward Pharms Int, Baxter Hlthcare Corp, Roche, Intl Medicated, Bedford, Gland Pharma Ltd, Fresenius Kabi Usa, HLR, Ben Venue, Hospira, Hi Tech Pharma, Sun Pharm Inds Ltd, Igi Labs Inc, Paddock Llc, and Akorn Inc, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for midazolam hydrochloride. Twenty-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: midazolam hydrochloride

US Patents:0
Tradenames:4
Applicants:22
NDAs:36
Drug Master File Entries: see list9
Suppliers / Packagers: see list22
Bulk Api Vendors: see list19
Clinical Trials: see list3,014
Patent Applications: see list1,221
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:midazolam hydrochloride at DailyMed

Pharmacology for Ingredient: midazolam hydrochloride

Ingredient-typeBenzodiazepines
Drug ClassBenzodiazepine

Tentative approvals for MIDAZOLAM HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 5MG BASE/MLINJECTABLE;INJECTION
u► SubscribeEQ 5MG BASE/MLINJECTABLE;INJECTION
u► SubscribeEQ 5MG BASE/MLINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION078511-001Nov 10, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Igi Labs Inc
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075263-001Jun 26, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075409-001Jun 20, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075243-002Jun 20, 2000APRXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075324-002Jun 20, 2000APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION075857-001Jul 22, 2002APRXNoYes► Subscribe► Subscribe► Subscribe
Hospira
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075856-001Jun 13, 2002APRXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075247-001Jun 23, 2000APRXNoNo► Subscribe► Subscribe► Subscribe
Sagent Agila Llc
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION090315-002Nov 29, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Baxter Hlthcare Corp
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075637-002Oct 31, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: midazolam hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
VERSED
midazolam hydrochloride
SYRUP;ORAL020942-001Oct 15, 1998► Subscribe► Subscribe
Hlr
VERSED
midazolam hydrochloride
INJECTABLE;INJECTION018654-001Dec 20, 1985► Subscribe► Subscribe
Hlr
VERSED
midazolam hydrochloride
INJECTABLE;INJECTION018654-002May 26, 1987► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Cerilliant
Moodys
AstraZeneca
Express Scripts
Harvard Business School
Healthtrust
Merck
Chubb

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.

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