Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SYSTEM;TRANSDERMAL | 5MG/24HR | 0 | ADLARITY | DONEPEZIL HYDROCHLORIDE |
002 | SYSTEM;TRANSDERMAL | 10MG/24HR | 0 | ADLARITY | DONEPEZIL HYDROCHLORIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2022-03-11 | STANDARD |
Submissions Property Types
CDER Filings
CORIUM, INC.
cder:Array
(
[0] => Array
(
[ApplNo] => 212304
[companyName] => CORIUM, INC.
[docInserts] => ["",""]
[products] => [{"drugName":"ADLARITY","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ADLARITY","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/11\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212304s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212304s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212304Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-03-11
)
)