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Serving leading biopharmaceutical companies globally:

Fish and Richardson
UBS
McKesson
Medtronic
Farmers Insurance
US Army
Express Scripts
Cantor Fitzgerald
Daiichi Sankyo
Boehringer Ingelheim

Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075857

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NDA 075857 describes MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Sagent Agila Llc, Hospira, and Fresenius Kabi Usa, 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 075857

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 075857

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 075857

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION 075857 ANDA Hospira, Inc. 0409-2305 0409-2305-21 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-2305-21) > 2 mL in 1 VIAL, SINGLE-DOSE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION 075857 ANDA Hospira, Inc. 0409-2305 0409-2305-50 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2305-50) > 5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Jul 22, 2002TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jul 22, 2002TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Boehringer Ingelheim
Fuji
Harvard Business School
Deloitte
US Department of Justice
Chinese Patent Office
Teva
US Army

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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