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Covington
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Fish and Richardson
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Federal Trade Commission
McKinsey
Citi
Chubb
Argus Health

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075856

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NDA 075856 describes MIDAZOLAM HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, West-ward Pharms Int, Wockhardt, Apotex Inc, Hi Tech Pharma, Paddock Llc, Sun Pharm Inds Ltd, and Mylan Asi, and is included in thirty-three NDAs. It is available from twenty-one suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE profile page.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE 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 075856
Tradename:MIDAZOLAM HYDROCHLORIDE
Applicant:Hospira
Ingredient:midazolam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075856
Ingredient-typeBenzodiazepines
Suppliers and Packaging for NDA: 075856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075856 ANDA Hospira, Inc. 0409-2306 N 0409-2306-12
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075856 ANDA Hospira, Inc. 0409-2306 N 0409-2306-62

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Jun 13, 2002TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jun 13, 2002TE:APRLD:No

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