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Last Updated: February 21, 2026

Details for New Drug Application (NDA): 219558

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NDA 219558 describes LINEZOLID, which is a drug marketed by Hetero Labs, Hikma, Caplin, 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-six NDAs. It is available from twenty-two 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-five suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for 219558

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

Pharmacology for NDA: 219558

Medical Subject Heading (MeSH) Categories for 219558

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 219558

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	219558	ANDA	Caplin Steriles Limited	65145-181	65145-181-10	10 POUCH in 1 CASE (65145-181-10) / 1 BAG in 1 POUCH (65145-181-01) / 300 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	600MG/300ML (2MG/ML)
Approval Date:	Dec 8, 2025	TE:	AP	RLD:	No

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