ANDA 205604

FRESENIUS KABI USA

FDA Drug Application

Application #205604

Documents

• Letter: 2015-12-11

Application Sponsors

ANDA 205604

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 250MG BASE/ML

0

AMIKACIN SULFATE

AMIKACIN SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205604
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"EQ 250MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205604Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-09
        )

)