NDA 215019

EDENBRIDGE PHARMS

FDA Drug Application

Application #215019

Documents

• Label: 2021-12-17
• Letter: 2021-12-21
• Review: 2022-07-27

Application Sponsors

NDA 215019

EDENBRIDGE PHARMS

Marketing Status

• Prescription: 001

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

ORIG

1

Null

15

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
        )

)