ANDA 216187

CHANGZHOU PHARM

FDA Drug Application

Application #216187

Application Sponsors

ANDA 216187

CHANGZHOU PHARM

Marketing Status

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

Application Products

001	TABLET;ORAL	60MG	0	TICAGRELOR	TICAGRELOR
002	TABLET;ORAL	90MG	0	TICAGRELOR	TICAGRELOR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

CHANGZHOU PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216187
            [companyName] => CHANGZHOU PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-12
        )

)