FDA.reportPublic FDA data

Application 021130

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYVOXLINEZOLIDTABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ZYVOXLINEZOLIDTABLET;ORAL600MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5138ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5138ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0093-8244LINEZOLIDLinezolidTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
21695-399ZyvoxlinezolidRebel Distributors CorpNDACurrent
59762-1307LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1307LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1307LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1307LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1307LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1307LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
60505-4362LINEZOLIDLinezolidApotex Corp.NDA AUTHORIZED GENERICCurrent
70518-1226ZyvoxlinezolidREMEDYREPACK INC.NDACurrent
70518-1226ZyvoxlinezolidREMEDYREPACK INC.NDACurrent
70518-1226ZyvoxlinezolidREMEDYREPACK INC.NDACurrent
70518-1226ZyvoxlinezolidREMEDYREPACK INC.NDACurrent
70518-1226ZyvoxlinezolidREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78933SUPPL 2024-06-28
78927SUPPL 2024-06-28
74805SUPPL 2023-07-20
74795SUPPL 2023-07-19
69143SUPPL2021-10-27
69128SUPPL2021-10-27
68590SUPPL2021-09-13
68515SUPPL2021-09-02
68132SUPPL2021-07-20
68119SUPPL2021-07-19
64222SUPPL2020-08-06
64221SUPPL2020-08-06
64214SUPPL2020-08-06
64213SUPPL2020-08-06
52295SUPPL2018-02-02
52264SUPPL2018-02-02
48994SUPPL2017-07-14
48993SUPPL2017-07-14
26853SUPPL2015-06-10
14461SUPPL2015-06-10
41970SUPPL2014-07-07
4412SUPPL2014-01-28
36174SUPPL2014-01-27
36172SUPPL2013-05-09
14460SUPPL2013-05-09
4411SUPPL2013-05-07
4410SUPPL2013-05-07
26852SUPPL2012-02-15
36173SUPPL2012-02-14
4409SUPPL2010-07-23
36171SUPPL2010-07-19
4408SUPPL2010-01-26
14459SUPPL2009-12-11
14458SUPPL2008-06-26
26851SUPPL2008-06-24
26850SUPPL2008-06-24
14457SUPPL2007-05-01
4407SUPPL2007-05-01
4406SUPPL2005-11-08
41969SUPPL2005-06-27
36170SUPPL2005-05-17
26849SUPPL2005-05-17
26848SUPPL2005-05-17
14456SUPPL2005-05-17
26847SUPPL2005-02-11
26844SUPPL2004-07-01
26843SUPPL2004-07-01
14455SUPPL2004-06-25
4405SUPPL2004-06-25
26846SUPPL2004-01-14
26845SUPPL2003-07-28
14454SUPPL2003-04-07
14453SUPPL2003-04-07
41968ORIG2000-04-18
14452ORIG2000-04-18
4404ORIG2000-04-18
52025ORIG1900-01-01
52024ORIG1900-01-01
52023ORIG1900-01-01
52022ORIG1900-01-01
52021ORIG1900-01-01
52020ORIG1900-01-01
52019ORIG1900-01-01