ANDA 208786

MYLAN LABS LTD

FDA Drug Application

Application #208786

Documents

• Letter: 2019-07-05

Application Sponsors

ANDA 208786

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INTRAVENOUS

37.5MG/ML (37.5MG/ML)

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208786
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"37.5MG\/ML (37.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208786Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-18
        )

)