ANDA 213778

ASPIRO

FDA Drug Application

Application #213778

Application Sponsors

ANDA 213778

ASPIRO

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 40MG BASE/VIAL

0

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-01-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

ASPIRO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213778
            [companyName] => ASPIRO
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"40MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-24
        )

)