MSN LABS PVT LTD FDA Approval ANDA 214366

ANDA 214366

MSN LABS PVT LTD

FDA Drug Application

Application #214366

Application Sponsors

ANDA 214366MSN LABS PVT LTD

Marketing Status

None (Tentative Approval)001
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; ORIG1TA2020-10-08STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MSN LABS PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214366
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"Erlotinib Hydrochloride","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-08
        )

)

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