GENUS FDA Approval ANDA 214542

ANDA 214542

GENUS

FDA Drug Application

Application #214542

Application Sponsors

ANDA 214542GENUS

Marketing Status

Prescription001
Prescription002

Application Products

001CONCENTRATE;ORAL30MG/ML0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
002CONCENTRATE;ORAL100MG/ML0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-02STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

GENUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214542
            [companyName] => GENUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"30MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-02
        )

)

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