Documents
Application Sponsors
| NDA 021131 | PHARMACIA AND UPJOHN | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Prescription | 003 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | 1 | ZYVOX | LINEZOLID |
| 002 | SOLUTION;INTRAVENOUS | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZYVOX | LINEZOLID |
| 003 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | 1 | ZYVOX | LINEZOLID |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-04-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2002-12-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2002-12-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2003-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2004-01-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2004-06-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2005-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2005-05-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2005-05-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 2005-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2008-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2008-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2007-08-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2007-09-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2009-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2010-07-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2013-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2013-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2012-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2014-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2014-07-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 2017-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2015-06-05 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 30 | AP | 2018-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2020-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2020-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2021-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2021-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2021-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2021-11-10 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 9 |
| SUPPL | 10 | Null | 8 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 37 | Null | 15 |
| SUPPL | 38 | Null | 31 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 003 | Prescription | AP |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 21131
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"ZYVOX","activeIngredients":"LINEZOLID","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZYVOX","activeIngredients":"LINEZOLID","strength":"400MG\/200ML (2MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZYVOX","activeIngredients":"LINEZOLID","strength":"600MG\/300ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/10\/2021","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021131s040lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2021","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021130s043,021131s039,021132s042lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2021","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021130s042,021131s038,021132s041lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2021","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021130s041,021131s037,021132s040lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2020","submission":"SUPPL-35","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021130s039s040,021131s034s035,021132s038s039lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2020","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021130s039s040,021131s034s035,021132s038s039lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021130s039s040,021131s034s035,021132s038s039lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021130s037,021131s030,021132s035lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021130s030,021131s029,021132s034lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/24\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021130s032,021131s026,021132s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021130s023s024,021131s021s022,021132s022s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2013","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021130s023s024,021131s021s022,021132s022s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2012","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021131s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2010","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021131s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021130s020,021131s017,021132s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2008","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021130s016,021131s013,021132s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2007","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021130s012,021131s012,021132s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2005","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021130s008,009,021131s009,010,021132s008,009lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2005","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021130s008,009,021131s009,010,021132s008,009lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2004","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2002","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2002","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21130lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZYVOX","submission":"LINEZOLID","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZYVOX","submission":"LINEZOLID","actionType":"400MG\/200ML (2MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZYVOX","submission":"LINEZOLID","actionType":"600MG\/300ML (2MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-11-10
)
)