Documents
Application Sponsors
| ANDA 205154 | MYLAN LABS LTD | |
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
| UNKNOWN; | ORIG | 1 | AP | 2017-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-05-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
MYLAN LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205154
[companyName] => MYLAN LABS LTD
[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":"12\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205154Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/27\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-06-27
)
)