Documents
Application Sponsors
NDA 212576 | ASTEX PHARMACEUTICALS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 35MG;100MG | 2 | INQOVI | DECITABINE;CEDAZURIDINE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-07-07 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 2022-03-24 | STANDARD |
Submissions Property Types
CDER Filings
ASTEX PHARMACEUTICALS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212576
[companyName] => ASTEX PHARMACEUTICALS INC
[docInserts] => ["",""]
[products] => [{"drugName":"INQOVI","activeIngredients":"DECITABINE;CEDAZURIDINE","strength":"35MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"07\/07\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212576s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212576s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212576Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-07-07
)
)