AUROBINDO PHARMA LTD FDA Approval ANDA 215357

ANDA 215357

AUROBINDO PHARMA LTD

FDA Drug Application

Application #215357

Application Sponsors

ANDA 215357AUROBINDO PHARMA LTD

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TROCHE/LOZENGE;ORALEQ 2MG BASE0NICOTINE POLACRILEXNICOTINE POLACRILEX
002TROCHE/LOZENGE;ORALEQ 4MG BASE0NICOTINE POLACRILEXNICOTINE POLACRILEX

FDA Submissions

UNKNOWN; ORIG1AP2022-05-13STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215357
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICOTINE POLACRILEX","activeIngredients":"NICOTINE POLACRILEX","strength":"EQ 2MG BASE","dosageForm":"TROCHE\/LOZENGE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"NICOTINE POLACRILEX","activeIngredients":"NICOTINE POLACRILEX","strength":"EQ 4MG BASE","dosageForm":"TROCHE\/LOZENGE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-13
        )

)

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