ANDA 204620

MICRO LABS LTD INDIA

FDA Drug Application

Application #204620

Application Sponsors

ANDA 204620

MICRO LABS LTD INDIA

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.2% BASE

0

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-16

Submissions Property Types

ORIG

1

Null

15

CDER Filings

MICRO LABS LTD INDIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204620
            [companyName] => MICRO LABS LTD INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"EQ 0.2% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-16
        )

)