ANDA 208508

HEC PHARM CO LTD

FDA Drug Application

Application #208508

Documents

• Letter: 2018-08-27

Application Sponsors

ANDA 208508

HEC PHARM CO LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

90MG

0

TICAGRELOR

TICAGRELOR

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-04-06	STANDARD
UNKNOWN;	ORIG	2	TA	2020-04-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	31

TE Codes

001

Prescription

AB

CDER Filings

SUNSHINE

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(
    [0] => Array
        (
            [ApplNo] => 208508
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208508Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-06
        )

)