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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Deloitte
Express Scripts
Covington
Moodys
Boehringer Ingelheim
UBS
Farmers Insurance
US Department of Justice

Generated: January 19, 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 Sagent Agila Llc, 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 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 0054-3566-99 118 mL in 1 BOTTLE, GLASS (0054-3566-99)
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 075873 ANDA Atlantic Biologicals Corps 17856-3566 17856-3566-3 5 mL in 1 CUP (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 leading biopharmaceutical companies globally:

QuintilesIMS
US Army
UBS
Baxter
Chinese Patent Office
Mallinckrodt
Cantor Fitzgerald
Fish and Richardson
Accenture

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