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Serving leading biopharmaceutical companies globally:

AstraZeneca
US Army
Dow
Daiichi Sankyo
Chubb
Johnson and Johnson
Accenture
QuintilesIMS
Covington
Chinese Patent Office

Generated: January 22, 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-six 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-nine 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 0781-3056-70 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3056-70) > 10 mL in 1 VIAL, MULTI-DOSE

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 leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
US Army
Fuji
McKinsey
Accenture
Moodys
US Department of Justice
AstraZeneca

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