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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 210378

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NDA 210378 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 210378

Tradename:	LINEZOLID
Applicant:	Macleods Pharms Ltd
Ingredient:	linezolid
Patents:	0

Pharmacology for NDA: 210378

Medical Subject Heading (MeSH) Categories for 210378

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 210378

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LINEZOLID	linezolid	TABLET;ORAL	210378	ANDA	Macleods Pharmaceuticals Limited	33342-352	33342-352-11	100 TABLET, COATED in 1 BOTTLE (33342-352-11)
LINEZOLID	linezolid	TABLET;ORAL	210378	ANDA	Macleods Pharmaceuticals Limited	33342-352	33342-352-31	5 BLISTER PACK in 1 CARTON (33342-352-31) / 10 TABLET, COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Oct 10, 2024	TE:		RLD:	No

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