ANDA 203453

MYLAN LABS LTD

FDA Drug Application

Application #203453

Documents

• Letter: 2017-03-29

Application Sponsors

ANDA 203453

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

0

GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-01-31

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203453
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 4MG BASE\/4ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203453Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-31
        )

)