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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 205154

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NDA 205154 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 205154

Tradename:	LINEZOLID
Applicant:	Pharmobedient
Ingredient:	linezolid
Patents:	0

Medical Subject Heading (MeSH) Categories for 205154

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/100ML (2MG/ML)
Approval Date:	Dec 6, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	600MG/300ML (2MG/ML)
Approval Date:	Dec 6, 2017	TE:	AP	RLD:	No

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