linezolid Injection

Brand(s)
Zyvox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-08-31)
Oldest Current Product
2000-04-18
License(s)
NDA, ANDA
RxNORM
INJECTION\LINEZOLID
FDAOB
IV (INFUSION)\SOLUTION\LINEZOLID\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\LINEZOLID
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\LINEZOLID

product(s) by strength(s)

300 ml linezolid 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000094992ZyvoxNDAPharmacia And Upjohn Company2015-07-06LINEZOLIDINTRAVENOUSINJECTION, SOLUTIONNDA021131122faa9e-c71a-4597-9552-5fb330b7d8b9
2000097807ZyvoxNDAPharmacia And Upjohn Company2015-02-18LINEZOLIDINTRAVENOUSINJECTION, SOLUTIONNDA0211313e5e9975-6f36-42e4-ab46-0e75dda83592
3004094883NDAHospira, Inc.2015-06-18LINEZOLIDINTRAVENOUSINJECTION, SOLUTIONNDA206473c401f1a8-cc37-461b-bfef-f2e156629bf8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007039060ANDATeva Parenteral Medicines, Inc2015-01-05LINEZOLIDINTRAVENOUSINJECTION, SOLUTIONANDA200222fc88377c-6580-4d03-befe-0c0b42d167ab

200 ml linezolid 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095139ZyvoxNDAPharmacia And Upjohn Company2000-04-18LINEZOLIDINTRAVENOUSINJECTION, SOLUTIONNDA0211316e70e63b-bfd5-478d-a8ee-8ba22c9efabd

100 ml linezolid 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095137ZyvoxNDAPharmacia And Upjohn Company2000-04-18LINEZOLIDINTRAVENOUSINJECTION, SOLUTIONNDA0211316e70e63b-bfd5-478d-a8ee-8ba22c9efabd

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA200222LINEZOLIDTEVA PHARMACEUTICALS USA2012-06-27PATENT CHALLENGE [2015-07-04]ANDA200222_001
2ANDA200904LINEZOLIDSANDOZ INC2015-07-16ANDA200904_001, ANDA200904_002
3ANDA205442LINEZOLIDHOSPIRA INC2015-07-07ANDA205442_001
4NDA021131ZYVOXPHARMACIA AND UPJOHN CO2000-04-18p6559305
p5688792, TREATMENT OF MICROBIAL INFECTIONS
NDA021131_001, NDA021131_002, NDA021131_003
5NDA206473LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRA INC2015-06-18NDA206473_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA200222_001RXLINEZOLID (600MG/300ML)SOLUTIONFalseAP2012-06-27LINEZOLID
2ANDA200904_001RXLINEZOLID (200MG/100ML)SOLUTIONFalseAP2015-07-16LINEZOLID
3ANDA200904_002RXLINEZOLID (600MG/300ML)SOLUTIONFalseAP2015-07-16LINEZOLID
4ANDA205442_001RXLINEZOLID (600MG/300ML)SOLUTIONFalseAP2015-07-07LINEZOLID
5NDA021131_001RXLINEZOLID (200MG/100ML)SOLUTIONFalseAP2000-04-18ZYVOX
6NDA021131_002RXLINEZOLID (400MG/200ML)SOLUTIONFalse2000-04-18ZYVOX
7NDA021131_003RXLINEZOLID (600MG/300ML)SOLUTIONTrueAP2000-04-18ZYVOX
8NDA206473_001RXLINEZOLID (600MG/300ML)SOLUTIONTrue2015-06-18LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5688792 (view patent)2014-11-18NDA021131, NDA021130, NDA021132linezolid Oral Suspension
linezolid Oral Tablet
2p6559305 (view patent)2021-01-29NDA021131, NDA021130, NDA021132linezolid Oral Suspension
linezolid Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1122faa9e-c71a-4597-9552-5fb330b7d8b9 (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) injectionInitial U.S. Approval: 2000prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-08-314000094992
23e5e9975-6f36-42e4-ab46-0e75dda83592 (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 Initial U.S. Approval: 2000prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE2015-08-313000097807
35ec10db9-6026-41fa-8abf-c86449392033 (view SPL)These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION.LINEZOLID INJECTION, for intravenous useInitial U.S. Approval: 2000prescriptionHuman PrescriptionHospira, Inc.2015-06-181004094882
46e70e63b-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, REPACK2015-07-3133000095137, 000095139, 000095135, 000095136, 000095138, 000095140linezolid Oral Suspension
linezolid Oral Tablet
5c401f1a8-cc37-461b-bfef-f2e156629bf8 (view SPL)These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection.LINEZOLID injection, for intravenous useInitial U.S. Approval: 2000prescriptionHuman PrescriptionHospira, Inc.2015-06-151004094883
6fc88377c-6580-4d03-befe-0c0b42d167ab (view SPL)These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection for intravenous useInitial U.S. Approval: 2000prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-09-223007039060

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