Last Updated: September 24, 2026

Details for New Drug Application (NDA): 085784

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NDA 085784 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-three NDAs. It is available from fourteen suppliers. Additional details are available on the ISONIAZID profile page.

The generic ingredient in ISONIAZID is isoniazid. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

Summary for 085784

Tradename:	ISONIAZID
Applicant:	Watson Labs
Ingredient:	isoniazid
Patents:	0

Medical Subject Heading (MeSH) Categories for 085784

Antitubercular Agents
Fatty Acid Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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