ANDA 216119

JIANGSU HANSOH PHARM

FDA Drug Application

Application #216119

Application Sponsors

ANDA 216119

JIANGSU HANSOH PHARM

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET;ORAL	5MG	0	DAPAGLIFLOZIN	DAPAGLIFLOZIN
002	TABLET;ORAL	10MG	0	DAPAGLIFLOZIN	DAPAGLIFLOZIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

JIANGSU HANSOH PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216119
            [companyName] => JIANGSU HANSOH PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPAGLIFLOZIN","activeIngredients":"DAPAGLIFLOZIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DAPAGLIFLOZIN","activeIngredients":"DAPAGLIFLOZIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/01\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-01
        )

)