Documents
Application Sponsors
ANDA 210332 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | 0 | DEXTROSE 5% AND LACTATED RINGER'S | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-03-28 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 210332
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"DEXTROSE 5% AND LACTATED RINGER'S","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"20MG\/100ML;5GM\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-03-28
)
)