Application Sponsors
ANDA 206554 | NANG KUANG PHARM CO | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
002 | POWDER;IV (INFUSION) | 100MG/VIAL | 0 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-01-26 | STANDARD |
Submissions Property Types
CDER Filings
NANG KUANG PHARM CO
cder:Array
(
[0] => Array
(
[ApplNo] => 206554
[companyName] => NANG KUANG PHARM CO
[docInserts] => ["",""]
[products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"25MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/26\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-01-26
)
)