Application Sponsors
ANDA 206486 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 1GM/100ML | 0 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-03-07 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 206486
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"1GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-03-07
)
)