Application Sponsors
| ANDA 203129 | FRESENIUS KABI USA | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | EQ 4MG PHOSPHATE/ML | 0 | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-09-30 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-07-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2022-01-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 203129
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"DEXAMETHASONE SODIUM PHOSPHATE","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 4MG PHOSPHATE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/28\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/09\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-28
)
)