ANDA 208575

HISUN PHARM HANGZHOU

FDA Drug Application

Application #208575

Documents

• Letter: 2018-11-16

Application Sponsors

ANDA 208575

HISUN PHARM HANGZHOU

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

90MG

0

TICAGRELOR

TICAGRELOR

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-02-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HISUN PHARM HANGZHOU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208575
            [companyName] => HISUN PHARM HANGZHOU
            [docInserts] => ["",""]
            [products] => [{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208575Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/05\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-05
        )

)