Application Sponsors
ANDA 211382 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 1MG BASE/ML | 0 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-11-03 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 211382
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"NOREPINEPHRINE BITARTRATE","activeIngredients":"NOREPINEPHRINE BITARTRATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-11-03
)
)