ANDA 207181

DEVA HOLDING AS

FDA Drug Application

Application #207181

Application Sponsors

ANDA 207181

DEVA HOLDING AS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 40MG BASE/VIAL

0

ESOMEPRAZOLE SODIUM

ESOMEPRAZOLE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-03-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

DEVA HOLDING AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207181
            [companyName] => DEVA HOLDING AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-06
        )

)