ALEMBIC PHARMS LTD FDA Approval ANDA 210263

ANDA 210263

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210263

Application Sponsors

ANDA 210263ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.03%0BIMATOPROSTBIMATOPROST

FDA Submissions

UNKNOWN; ORIG1AP2019-04-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210263
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-12
        )

)

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