Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 23MG | 0 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-02-19 | |
LABELING; Labeling | SUPPL | 3 | AP | 2019-09-20 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
DEXCEL PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 203713
[companyName] => DEXCEL PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/20\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-20
)
)