ALEMBIC PHARMS LTD FDA Approval ANDA 214719

ANDA 214719

ALEMBIC PHARMS LTD

FDA Drug Application

Application #214719

Application Sponsors

ANDA 214719ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 25MG BASE0ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
002TABLET;ORALEQ 100MG BASE0ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
003TABLET;ORALEQ 150MG BASE0ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214719
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERLOTINIB HYDROCHLORIDE","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERLOTINIB HYDROCHLORIDE","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERLOTINIB HYDROCHLORIDE","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-08
        )

)

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