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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 080132

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NDA 080132 describes ISONIAZID, which is a drug marketed by Sandoz, Chartwell Rx, Cmp Pharma Inc, Duramed Pharms Barr, Epic Pharma Llc, Genus, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Omnivium Pharms, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, and Whiteworth Town Plsn, and is included in thirty-four NDAs. It is available from sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

Summary for 080132

Tradename:	ISONIAZID
Applicant:	Purepac Pharm
Ingredient:	isoniazid
Patents:	0

Medical Subject Heading (MeSH) Categories for 080132

Antitubercular Agents
Fatty Acid Synthesis Inhibitors

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 14, 1982	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 14, 1982	TE:		RLD:	No

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