linezolid Oral Suspension

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, ANDA
RxNORM
ORAL SUSPENSION\LINEZOLID
FDAOB
ORAL\FOR SUSPENSION\LINEZOLID
SPL Active
ORAL\POWDER, FOR SUSPENSION\LINEZOLID
ORAL\SUSPENSION\LINEZOLID
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\LINEZOLID
ORAL\SUSPENSION\LINEZOLID

product(s) by strength(s)

linezolid 20 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095136ZyvoxNDAPharmacia And Upjohn Company2000-04-18LINEZOLIDORALSUSPENSIONNDA0211326e70e63b-bfd5-478d-a8ee-8ba22c9efabd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540319ANDARoxane Laboratories, Inc2015-11-18LINEZOLIDORALPOWDER, FOR SUSPENSIONANDA20006816007ca5-7956-4414-af38-406a6623400e

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA200068LINEZOLIDROXANE LABORATORIES INC2015-06-03ANDA200068_001linezolid Oral Tablet
2NDA021132ZYVOXPHARMACIA AND UPJOHN CO2000-04-18p6559305
p5688792, TREATMENT OF MICROBIAL INFECTIONS
NDA021132_001linezolid Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200068_001RXLINEZOLID (100MG/5ML)ORALFOR SUSPENSIONFalseAB2015-06-03LINEZOLID
2NDA021132_001RXLINEZOLID (100MG/5ML)ORALFOR SUSPENSIONTrueAB2000-04-18ZYVOX

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
116007ca5-7956-4414-af38-406a6623400e (view SPL)These highlights do not include all the information needed to use LINEZOLID for Oral Suspension safely and effectively. See full prescribing information for LINEZOLID for Oral Suspension. LINEZOLID for Oral SuspensionInitial U.S. Approval: 2000To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-11-181000540319
26e70e63b-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, REPACK2015-07-3133000095136, 000095135, 000095137, 000095138, 000095139, 000095140linezolid Oral Tablet
linezolid Injection

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