Application Sponsors
ANDA 211276 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | UNKNOWN | UNKNOWN | 0 | DEXTROSE;SODIUM CHLORIDE | DEXTROSE;SODIUM CHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-09-15 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 211276
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-15
)
)