ALEMBIC PHARMS LTD FDA Approval ANDA 209919

ANDA 209919

ALEMBIC PHARMS LTD

FDA Drug Application

Application #209919

Application Sponsors

ANDA 209919ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.1% BASE0OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-12-07STANDARD
LABELING; LabelingSUPPL2AP2021-02-18STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAT

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209919
            [companyName] => ALEMBIC PHARMS LTD
            [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":"12\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-07
        )

)

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