ANDA 208908

HOSPIRA INC

FDA Drug Application

Application #208908

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 208908

HOSPIRA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

UNKNOWN

UNKNOWN

0

EPINEPHRINE

EPINEPHRINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208908
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINEPHRINE","activeIngredients":"EPINEPHRINE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-17
        )

)