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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080522

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NDA 080522 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 080522

Tradename:	ISONIAZID
Applicant:	Watson Labs
Ingredient:	isoniazid
Patents:	0
Therapeutic Class:	Antimycobacterials
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 080522

Antitubercular Agents
Fatty Acid Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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