ANDA 214349

HOSPIRA INC

FDA Drug Application

Application #214349

Application Sponsors

ANDA 214349

HOSPIRA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INTRAVENOUS

0.4MG/5ML (0.08MG/ML)

0

REGADENOSON

REGADENOSON

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-02-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214349
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REGADENOSON INJECTION","activeIngredients":"REGADENOSON","strength":"04.MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/24\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-24
        )

)