AKORN INC FDA Approval ANDA 204532

ANDA 204532

AKORN INC

FDA Drug Application

Application #204532

Application Sponsors

ANDA 204532AKORN INC

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.1% BASE0OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-01-10
LABELING; LabelingSUPPL4AP2021-06-23STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7

TE Codes

001PrescriptionAT

CDER Filings

AKORN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204532
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"EQ 0.1% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/10\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-10
        )

)

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