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LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

NDA

LINEZOLID | N206473 | HOSPIRA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

101 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 76 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB NCT03828201	Phase 2	Active	Boston University	271	2022-06-07 → 2027-05
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment NCT04310930	Phase 2/3	Recruiting	The University of Queensland	300	2020-03-02 → 2030-06-30
Evaluation Of Linezolid Pk Profile In Burns Patients NCT00255996	Phase 1	Completed	Pfizer	16	2006-05 → 2007-01
Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)NCT00303550	Phase 3	Completed	Arpida AG	—	2006-03
Population Pharmacokinetics of Linezolid NCT01200654	Phase 4	Completed	University Hospital, Toulouse	60	2007-11 → 2010-08
Treatment Shortening of MDR-TB Using Existing and New Drugs NCT02619994	Phase 2	Completed	Seoul National University Hospital	214	2016-01 → 2021-06
A Study To Assess The Effect Of Linezolid On QTc Interval NCT00795145	Phase 1	Completed	Pfizer	49	2008-12 → 2009-03
Linezolid to Treat Extensively-Drug Resistant Tuberculosis NCT00727844	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	41	2008-07 → 2014-11
Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia NCT00326287	Phase 3	Completed	Basilea Pharmaceutica	638	2006-06 → 2007-07
Study of Debio 1450 for Bacterial Skin Infections NCT02426918	Phase 2	Completed	Debiopharm International SA	330	2015-05 → 2016-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$368.03

Highest Price

$484.76

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00409-4883-10LINEZOLID-0.9% NACL 600 MG/300	$484.76	FSS	Pfizer Inc.	06/30/2029
00409-4883-10LINEZOLID-0.9% NACL 600 MG/300	$368.03	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain30 active DMFs5 inactive

24 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVLINEZOLID

DMF 190322005

ALIVUS LIFE SCIENCES LTDLINEZOLID

DMF 197462006

SYMED LABS LTDLINEZOLID (FORM III)

DMF 202692007

NEULAND LABORATORIES LTDLINEZOLID USP (FORM-II)

DMF 245062010

ALEMBIC PHARMACEUTICALS LTDLINEZOLID USP

DMF 247902011

DR REDDYS LABORATORIES LTDLINEZOLID

DMF 254252011

FORMOSA LABORATORIES INCLINEZOLID

DMF 257002012

RAKS PHARMA PVT LTDLINEZOLID USP

DMF 260422012

JUBILANT BIOSYS LTDLINEZOLID FORM 1

DMF 269282013

ZHEJIANG LEPU PHARMACEUTICAL CO LTDLINEZOLID (FORM I), NON-STERILE BULK DRUG SUBSTANCE

DMF 269622013

ZYDUS LIFESCIENCES LTDLINEZOLID

DMF 272332013

ALIVUS LIFE SCIENCES LTDLINEZOLID D111 PROCESS

DMF 274432013

ZHEJIANG HISUN PHARMACEUTICAL CO LTDLINEZOLID

DMF 285962014

SYMED LABS LTDLINEZOLID (FORM-II)

DMF 286422014

MACLEODS PHARMACEUTICALS LTDLINEZOLID

DMF 304862016

ALEMBIC PHARMACEUTICALS LTD API DIVLINEZOLID USP (FORM-I)

DMF 346482020

OPTIMUS DRUGS PRIVATE LTDLINEZOLID

DMF 351342020

CHROMO LABORATORIES INDIA PRIVATE LTDLINEZOLID USP

DMF 353042020

ALEMBIC PHARMACEUTICALS LTDLINEZOLID USP (FORM-II)

DMF 356072021

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDLINEZOLID

DMF 358912021

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDLINEZOLID USP (NON-STERILE API)

DMF 359382021

NEULAND LABORATORIES LTDLINEZOLID USP (PROCESS-II)

DMF 369462022

LEE PHARMA LTDLINEZOLID USP

DMF 377322022

GLAND PHARMA LTDLINEZOLID

DMF 377372022

CHONGQING HUAPONT PHARMACEUTICAL CO LTDLINEZOLID

DMF 379432023

OPTIMUS DRUGS PRIVATE LTDLINEZOLID USP (FORM-III)

DMF 411572024

APISYN HEALTHCARE PRIVATE LTDLINEZOLID (FORM-II)

DMF 423622025

APISYN HEALTHCARE PRIVATE LTDLINEZOLID (FORM-III)

DMF 423632025

JIANGSU CHIA TAI FENGHAI PHARMACEUTICAL CO LTDLINEZOLID

DMF 439222026

EMNAR PHARMA PRIVATE LTDLINEZOLID

DMF 439312026

APOTEX PHARMACHEM INDIA PVT LTDInactiveLINEZOLID

DMF 254922011

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveLINEZOLID

DMF 262002012

USV PRIVATE LTDInactiveLINEZOLID

DMF 267012012

AMOLI ORGANICS PVT LTDInactiveLINEZOLID [FORM-1]

DMF 275342013

AMOLI ORGANICS PVT LTDInactiveLINEZOLID [FORM-II]

DMF 276732013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jun 11, 2026	SUPPL -13	View Letter (PDF)
May 30, 2025	SUPPL -11	View Letter (PDF)
Nov 12, 2024	SUPPL -10	View Letter (PDF)
Feb 22, 2022	SUPPL -7	View Letter (PDF)
Jan 19, 2022	SUPPL -5	View Letter (PDF)
Aug 13, 2021	SUPPL -4	View Letter (PDF)
Aug 2, 2021	SUPPL -3	View Letter (PDF)
Aug 24, 2018	SUPPL -2	View Letter (PDF)
Dec 20, 2017	SUPPL -1	View Letter (PDF)
Jun 22, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG/300ML (2MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 18, 2015

No patent or exclusivity listings for this strength.