LANNETT CO INC FDA Approval ANDA 212996

ANDA 212996

LANNETT CO INC

FDA Drug Application

Application #212996

Application Sponsors

ANDA 212996LANNETT CO INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET;ORAL10MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
002TABLET;ORAL25MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
003TABLET;ORAL50MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
004TABLET;ORAL100MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE
005TABLET;ORAL200MG0CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212996
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"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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