ANDA 204400

HOSPIRA INC

FDA Drug Application

Application #204400

Application Sponsors

ANDA 204400

HOSPIRA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE; IV (INFUSION)

EQ 40MG BASE/VIAL

0

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-03-08

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204400
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE; IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-08
        )

)