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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 204239

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NDA 204239 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 204239

Tradename:	LINEZOLID
Applicant:	Hetero Labs Ltd V
Ingredient:	linezolid
Patents:	0

Pharmacology for NDA: 204239

Medical Subject Heading (MeSH) Categories for 204239

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 204239

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LINEZOLID	linezolid	TABLET;ORAL	204239	ANDA	Camber Pharmaceuticals, Inc.	31722-749	31722-749-01	100 TABLET, FILM COATED in 1 BOTTLE (31722-749-01)
LINEZOLID	linezolid	TABLET;ORAL	204239	ANDA	Camber Pharmaceuticals, Inc.	31722-749	31722-749-20	20 TABLET, FILM COATED in 1 BOTTLE (31722-749-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Dec 21, 2015	TE:	AB	RLD:	No

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