Documents
Application Sponsors
| NDA 021130 | PHARMACIA AND UPJOHN | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZYVOX | LINEZOLID |
| 002 | TABLET;ORAL | 600MG | 1 | ZYVOX | LINEZOLID |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | 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 | 5 | AP | 2004-01-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2004-06-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2005-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2005-05-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2005-05-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2005-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-04-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2007-03-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2007-03-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2007-06-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 2008-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2008-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2007-09-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2008-02-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 2009-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2010-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2013-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2013-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2012-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2014-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2014-07-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 2017-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | 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 | 37 | AP | 2018-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2020-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2020-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2021-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2021-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2021-10-26 | STANDARD |
Submissions Property Types
| SUPPL | 9 | Null | 6 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 37 | Null | 31 |
| SUPPL | 39 | Null | 15 |
| SUPPL | 40 | Null | 15 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 7 |
TE Codes
CDER Filings
PFIZER
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[originalApprovals] => [{"actionDate":"ZYVOX","submission":"LINEZOLID","actionType":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZYVOX","submission":"LINEZOLID","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-10-26
)
)