ANDA 203900

HOSPIRA INC

FDA Drug Application

Application #203900

Documents

• Letter: 2017-08-28

Application Sponsors

ANDA 203900

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

TACROLIMUS

TACROLIMUS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-25

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203900
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203900Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-25
        )

)