ANDA 204902

BARADAINA LLC

FDA Drug Application

Application #204902

Documents

• Letter: 2019-06-17

Application Sponsors

ANDA 204902

BARADAINA LLC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

DAPIPRAZOLE HYDROCHLORIDE

DAPIPRAZOLE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-29

STANDARD

Submissions Property Types

ORIG

1

Null

19

CDER Filings

WOODWARD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204902
            [companyName] => WOODWARD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPIPRAZOLE HYDROCHLORIDE","activeIngredients":"DAPIPRAZOLE HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204902Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-29
        )

)