ANDA 204732

MYLAN LABS LTD

FDA Drug Application

Application #204732

Documents

• Letter: 2017-01-31

Application Sponsors

ANDA 204732

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-01-26

Submissions Property Types

ORIG

1

Null

15

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204732
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204732Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-26
        )

)