Documents
Application Sponsors
ANDA 208575 | HISUN PHARM HANGZHOU | |
Marketing Status
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
TE Codes
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
)
)