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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Fish and Richardson
Cantor Fitzgerald
Federal Trade Commission

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076379

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NDA 076379 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 076379
Applicant:Paddock Llc
Ingredient:midazolam hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 076379
Suppliers and Packaging for NDA: 076379
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 076379 ANDA Paddock Laboratories, LLC 0574-0150 N 0574-0150-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 2MG BASE/ML
Approval Date:May 2, 2005TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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