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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Fuji
Harvard Business School
McKesson
Argus Health
Chubb
Baxter
Julphar

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075873

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NDA 075873 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 eighteen 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 suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 075873
Tradename:MIDAZOLAM HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:midazolam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075873
Ingredient-typeBenzodiazepines
Suppliers and Packaging for NDA: 075873
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 075873 ANDA West-Ward Pharmaceuticals Corp. 0054-3566 N 0054-3566-99
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 075873 ANDA Atlantic Biologicals Corps 17856-3566 N 17856-3566-3

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 2MG BASE/ML
Approval Date:Apr 30, 2002TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Baxter
US Army
Fish and Richardson
Boehringer Ingelheim
Medtronic
Fuji
Farmers Insurance
Johnson and Johnson

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