linezolid Oral Tablet

Brand(s)
Zyvox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-07-31)
Oldest Current Product
2000-04-18
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
ORAL TABLET\LINEZOLID
FDAOB
ORAL\FOR SUSPENSION\LINEZOLID
ORAL\TABLET\LINEZOLID
SPL Active
ORAL\TABLET, FILM COATED\LINEZOLID
SPL Moiety
ORAL\TABLET, FILM COATED\LINEZOLID

product(s) by strength(s)

linezolid 600 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095135ZyvoxNDAPharmacia And Upjohn Company2000-04-18LINEZOLIDORALTABLET, FILM COATEDNDA0211306e70e63b-bfd5-478d-a8ee-8ba22c9efabd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000938244NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-06-22LINEZOLIDORALTABLET, FILM COATEDNDA021132b65ee68a-c50d-4d5e-955b-dde0214e861b
2605054362NDA AUTHORIZED GENERICApotex Corp2015-06-22LINEZOLIDORALTABLET, FILM COATEDNDA0211322a02e028-263f-4673-ae85-19b784bd118c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950399ZyvoxNDARebel Distributors Corp2000-04-18LINEZOLIDORALTABLET, FILM COATED000095135NDA02113050630775-7f76-413e-9278-ba298dd7f187
2493490751ZyvoxNDARemedyrepack Inc.2013-04-03LINEZOLIDORALTABLET, FILM COATED000095135NDA021130dd26b439-35c6-4c6b-ba38-c1f4d2bf098a, e57716ab-7697-46cc-b612-e0e81414128f
3551543938ZyvoxNDACardinal Health2000-04-18LINEZOLIDORALTABLET, FILM COATED000095135NDA021130d76293c8-2642-4bfc-97bf-59e37251723d

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA078061LINEZOLIDTEVA PHARMACEUTICALS USA2015-05-18PATENT CHALLENGE [2015-12-19]ANDA078061_001
2ANDA200068LINEZOLIDROXANE LABORATORIES INC2015-06-03ANDA200068_001linezolid Oral Suspension
3NDA021130ZYVOXPHARMACIA AND UPJOHN CO2000-04-18p6559305
p5688792, TREATMENT OF MICROBIAL INFECTIONS
p6514529, SUBSTANCE
NDA021130_001, NDA021130_002
4NDA021132ZYVOXPHARMACIA AND UPJOHN CO2000-04-18p6559305
p5688792, TREATMENT OF MICROBIAL INFECTIONS
NDA021132_001linezolid Oral Suspension

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078061_001RXLINEZOLID (600MG)ORALTABLETFalseAB2015-05-18LINEZOLID
2ANDA200068_001RXLINEZOLID (100MG/5ML)ORALFOR SUSPENSIONFalseAB2015-06-03LINEZOLID
3NDA021130_001discontinuedLINEZOLID (400MG)ORALTABLETFalse2000-04-18ZYVOX
4NDA021130_002RXLINEZOLID (600MG)ORALTABLETTrueAB2000-04-18ZYVOX
5NDA021132_001RXLINEZOLID (100MG/5ML)ORALFOR SUSPENSIONTrueAB2000-04-18ZYVOX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5688792 (view patent)2014-11-18NDA021130, NDA021132, NDA021131linezolid Oral Suspension
linezolid Injection
2p6514529 (view patent)2021-03-15NDA021130
3p6559305 (view patent)2021-01-29NDA021130, NDA021132, NDA021131linezolid Oral Suspension
linezolid Injection

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12a02e028-263f-4673-ae85-19b784bd118c (view SPL)These highlights do not include all the information needed to use linezolid safely and effectively. See full prescribing information for linezolid. LINEZOLID TABLETSInitial U.S. Approval: 2000prescriptionHuman PrescriptionApotex Corp2015-08-312605054362
250630775-7f76-413e-9278-ba298dd7f187 (view SPL)ZYVOX (linezolid) injection(linezolid) tablets(linezolid) for oral suspensionprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-221216950399
36e70e63b-bfd5-478d-a8ee-8ba22c9efabd (view SPL)These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX (linezolid) injection, tablets and oral suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionPharmacia And Upjohn CompanyAPI MANUFACTURE, MANUFACTURE, PACK, REPACK2015-07-3133000095135, 000095136, 000095137, 000095138, 000095139, 000095140linezolid Oral Suspension
linezolid Injection
4b65ee68a-c50d-4d5e-955b-dde0214e861b (view SPL)These highlights do not include all the information needed to use linezolid safely and effectively. See full prescribing information for linezolid. LINEZOLID TABLETSInitial U.S. Approval: 2000prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-312000938244
5d76293c8-2642-4bfc-97bf-59e37251723d (view SPL)ZYVOX (linezolid) injection(linezolid) tablets(linezolid) for oral suspensionprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-071551543938
6dd26b439-35c6-4c6b-ba38-c1f4d2bf098a (view SPL)ZYVOX (linezolid) injection(linezolid) tablets(linezolid) for oral suspensionprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-031493490751
7e57716ab-7697-46cc-b612-e0e81414128f (view SPL)ZYVOX (linezolid) injection(linezolid) tablets(linezolid) for oral suspensionprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-031493490751

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII