GLENMARK PHARMS LTD FDA Approval ANDA 212144

ANDA 212144

GLENMARK PHARMS LTD

FDA Drug Application

Application #212144

Documents

Letter2021-04-13

Application Sponsors

ANDA 212144GLENMARK PHARMS LTD

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; ORIG1AP2021-03-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212144
            [companyName] => GLENMARK PHARMS LTD
            [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":"03\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-23
        )

)

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