MSN FDA Approval ANDA 214827

ANDA 214827

MSN

FDA Drug Application

Application #214827

Application Sponsors

ANDA 214827MSN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL25MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
002TABLET;ORAL50MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
003TABLET;ORAL100MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
004TABLET;ORAL200MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-01-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

MSN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214827
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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