ANDA 203492

MICRO LABS LTD INDIA

FDA Drug Application

Application #203492

Application Sponsors

ANDA 203492

MICRO LABS LTD INDIA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-06-20

Submissions Property Types

ORIG

1

Null

17

CDER Filings

MICRO LABS LTD INDIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203492
            [companyName] => MICRO LABS LTD INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/20\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-20
        )

)