Application Sponsors
ANDA 207354 | NANG KUANG PHARM CO | |
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 | 2016-12-20 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2019-05-28 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2019-05-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 7 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
NANG KUANG PHARM CO
cder:Array
(
[0] => Array
(
[ApplNo] => 207354
[companyName] => NANG KUANG PHARM CO
[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\/20\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/28\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-28
)
)