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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206097

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NDA 206097 describes LINEZOLID, which is a drug marketed by Hetero Labs, Hikma, Eugia Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Nang Kuang Pharm Co, Pharmobedient, Sagent Pharms Inc, Sandoz, Teva Pharms, Alembic, Alkem Labs Ltd, Amneal Pharms, Chartwell Rx, Gate Pharms, Glenmark Speclt, Hetero Labs Ltd V, Macleods Pharms Ltd, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-five NDAs. It is available from twenty-one suppliers. Additional details are available on the LINEZOLID profile page.

The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for 206097

Tradename:	LINEZOLID
Applicant:	Zydus Pharms
Ingredient:	linezolid
Patents:	0

Medical Subject Heading (MeSH) Categories for 206097

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Feb 22, 2017	TE:	AB	RLD:	No

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