CHANGZHOU PHARM FDA Approval ANDA 216187

ANDA 216187

CHANGZHOU PHARM

FDA Drug Application

Application #216187

Application Sponsors

ANDA 216187CHANGZHOU PHARM

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET;ORAL60MG0TICAGRELORTICAGRELOR
002TABLET;ORAL90MG0TICAGRELORTICAGRELOR

FDA Submissions

UNKNOWN; ORIG1TA2022-12-12STANDARD

Submissions Property Types

ORIG1Null31

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
        )

)

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