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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Cipla
Julphar
Healthtrust
Daiichi Sankyo
Moodys
Citi
US Army

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040648

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NDA 040648 describes ISONIAZID, which is a drug marketed by Sandoz Inc, Cmp Pharma Inc, Mikart, Barr, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sandoz, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, and Whiteworth Town Plsn, and is included in thirty-four NDAs. It is available from twenty-five suppliers. Additional details are available on the ISONIAZID profile page.

The generic ingredient in ISONIAZID is isoniazid. There are five drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the isoniazid profile page.
Summary for 040648
Tradename:ISONIAZID
Applicant:Sandoz Inc
Ingredient:isoniazid
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 040648
Medical Subject Heading (MeSH) Categories for 040648
Suppliers and Packaging for NDA: 040648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISONIAZID isoniazid INJECTABLE;INJECTION 040648 ANDA Sandoz Inc 0781-3056 N 0781-3056-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jul 5, 2005TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Queensland Health
Fish and Richardson
US Department of Justice
UBS
Teva
QuintilesIMS
Accenture
Federal Trade Commission

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