FDA.reportPublic FDA data

Application 021131

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYVOXLINEZOLIDSOLUTION;INTRAVENOUS200MG/100ML (2MG/ML)YesNo
002ZYVOXLINEZOLIDSOLUTION;INTRAVENOUS400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ZYVOXLINEZOLIDSOLUTION;INTRAVENOUS600MG/300ML (2MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-4992ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-4992ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5137ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5140ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-7807ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
66298-4992ZyvoxLINEZOLIDFresenius Kabi Norge AsNDACurrent
66298-5137ZyvoxLINEZOLIDFresenius Kabi Norge AsNDACurrent
66298-5140ZyvoxlinezolidFresenius Kabi Norge AsNDACurrent
66298-7807ZyvoxLINEZOLIDFresenius Kabi Norge AsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78934SUPPL 2024-06-28
78928SUPPL 2024-06-28
74806SUPPL 2023-07-20
74796SUPPL 2023-07-19
69296SUPPL2021-11-12
69292SUPPL2021-11-12
69144SUPPL2021-10-27
69129SUPPL2021-10-27
68591SUPPL2021-09-13
68516SUPPL2021-09-02
68133SUPPL2021-07-20
68120SUPPL2021-07-19
64224SUPPL2020-08-06
64223SUPPL2020-08-06
64216SUPPL2020-08-06
64215SUPPL2020-08-06
52296SUPPL2018-02-02
52265SUPPL2018-02-02
48995SUPPL2017-07-14
48992SUPPL2017-07-14
36183SUPPL2015-06-10
4424SUPPL2015-06-10
21466SUPPL2014-07-07
4423SUPPL2014-01-28
14467SUPPL2014-01-27
14466SUPPL2013-05-09
14465SUPPL2013-05-09
26860SUPPL2013-05-07
4422SUPPL2013-05-07
26861SUPPL2012-02-15
36182SUPPL2012-02-14
4421SUPPL2010-07-23
36181SUPPL2010-07-16
26859SUPPL2010-01-26
36180SUPPL2009-12-11
36179SUPPL2008-06-26
4420SUPPL2008-06-24
4419SUPPL2008-06-24
36178SUPPL2007-05-01
4418SUPPL2007-05-01
4417SUPPL2005-11-08
41971SUPPL2005-07-11
36177SUPPL2005-05-17
26858SUPPL2005-05-17
26857SUPPL2005-05-17
14464SUPPL2005-05-17
26856SUPPL2005-02-11
26854SUPPL2004-07-01
4414SUPPL2004-07-01
14463SUPPL2004-06-25
4416SUPPL2004-06-25
26855SUPPL2004-01-14
4415SUPPL2003-07-28
36176SUPPL2003-04-07
36175SUPPL2003-04-07
21465ORIG2000-04-18
14462ORIG2000-04-18
4413ORIG2000-04-18