Application Sponsors
ANDA 210410 | FRESENIUS KABI USA | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;IV (INFUSION) | 100MG/4ML (25MG/ML) | 0 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2018-11-13 | STANDARD |
Submissions Property Types
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 210410
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/4ML (25MG\/ML)","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/13\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-11-13
)
)