NDA 214278

Dexcel Pharma Technologies Ltd.

FDA Drug Application

Application #214278

Documents

• Letter: 2020-10-21
• Review: 2021-02-12
• Letter: 2021-09-09
• Letter: 2022-05-12
• Label: 2022-05-17

Application Sponsors

NDA 214278

Dexcel Pharma Technologies Ltd.

Marketing Status

• Prescription: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL

20MG

0

ESOMEPRAZOLE

ESOMEPRAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-10-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-05-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	6

CDER Filings

Dexcel Pharma Technologies Ltd.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214278
            [companyName] => Dexcel Pharma Technologies Ltd.
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE","activeIngredients":"ESOMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214278Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-20
        )

)