FDA.reportPublic FDA data

Application 021132

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYVOXLINEZOLIDFOR SUSPENSION;ORAL100MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5136ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia and Upjohn Company LLCNDACurrent
0009-5136ZyvoxlinezolidPharmacia & Upjohn Company LLCNDACurrent
55695-009ZyvoxlinezolidDepartment of State Health Services, Pharmacy BranchNDACurrent
59762-1308LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1308LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1308LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1308LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1308LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1308LinezolidlinezolidGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78935SUPPL 2024-06-28
78929SUPPL 2024-06-28
74807SUPPL 2023-07-20
74797SUPPL 2023-07-19
69145SUPPL2021-10-27
69130SUPPL2021-10-27
68592SUPPL2021-09-13
68517SUPPL2021-09-02
68134SUPPL2021-07-20
64226SUPPL2020-08-06
64225SUPPL2020-08-06
64218SUPPL2020-08-06
64217SUPPL2020-08-06
52297SUPPL2018-02-02
52266SUPPL2018-02-02
48996SUPPL2017-07-14
48991SUPPL2017-07-14
14472SUPPL2015-06-10
4433SUPPL2015-06-10
41973SUPPL2014-07-07
26872SUPPL2014-01-28
36193SUPPL2014-01-27
36191SUPPL2013-05-09
14471SUPPL2013-05-09
26871SUPPL2013-05-07
4431SUPPL2013-05-07
4432SUPPL2012-02-15
36192SUPPL2012-02-14
4430SUPPL2010-07-23
36190SUPPL2010-07-19
26870SUPPL2010-01-26
36189SUPPL2009-12-11
36188SUPPL2008-06-26
26869SUPPL2008-06-24
4429SUPPL2008-06-24
36187SUPPL2007-05-01
26868SUPPL2007-05-01
4428SUPPL2005-11-08
21467SUPPL2005-07-11
36186SUPPL2005-05-17
36185SUPPL2005-05-17
26867SUPPL2005-05-17
4427SUPPL2005-05-17
26866SUPPL2005-02-11
26863SUPPL2004-07-01
4425SUPPL2004-07-01
14470SUPPL2004-06-25
4426SUPPL2004-06-25
26865SUPPL2004-01-14
26864SUPPL2003-07-28
14469SUPPL2003-04-07
14468SUPPL2003-04-07
41972ORIG2000-04-18
36184ORIG2000-04-18
26862ORIG2000-04-18