Application Sponsors
| ANDA 078662 | ACI HEALTHCARE 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
| ORIG | 1 | AP | 2011-05-31 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-10-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ACI HEALTHCARE LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 78662
[companyName] => ACI HEALTHCARE 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":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)