Documents
Application Sponsors
NDA 215019 | EDENBRIDGE PHARMS | |
Marketing Status
Application Products
001 | TABLET;ORALLY DISINTEGRATING | 1.7MG | 0 | DARTISLA ODT | GLYCOPYRROLATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2021-12-16 | STANDARD |
Submissions Property Types
CDER Filings
EDENBRIDGE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 215019
[companyName] => EDENBRIDGE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DARTISLA ODT","activeIngredients":"GLYCOPYRROLATE","strength":"1.7MG","dosageForm":"TABLET;ORALLY DISINTEGRATING","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/16\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215019s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/16\/2021","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\\\/2021\\\/215019s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215019Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-12-16
)
)