Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | 0 | LINEZOLID | LINEZOLID |
| 002 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | 0 | LINEZOLID | LINEZOLID |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2015-07-16 | |
| N/A; Not Applicable | ORIG | 2 | AP | 2015-07-16 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-05-28 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-05-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| ORIG | 2 | Null | 19 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 8 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SANDOZ INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200904
[companyName] => SANDOZ INC
[docInserts] => ["",""]
[products] => [{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"600MG\/300ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/16\/2015","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200904Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200904Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/28\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-28
)
)