ALEMBIC PHARMS LTD FDA Approval ANDA 211731

ANDA 211731

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211731

Application Sponsors

ANDA 211731ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL4MG0SILODOSINSILODOSIN
002CAPSULE;ORAL8MG0SILODOSINSILODOSIN

FDA Submissions

UNKNOWN; ORIG1AP2019-11-22STANDARD
LABELING; LabelingSUPPL3AP2021-07-02STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211731
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-22
        )

)

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