Application Sponsors
ANDA 203656 | UNICHEM LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 5MG | 0 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE |
002 | TABLET;ORAL | 10MG | 0 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-06-23 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
UNICHEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203656
[companyName] => UNICHEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/20\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-20
)
)