ANDA 215357

AUROBINDO PHARMA LTD

FDA Drug Application

Application #215357

Application Sponsors

ANDA 215357

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	TROCHE/LOZENGE;ORAL	EQ 2MG BASE	0	NICOTINE POLACRILEX	NICOTINE POLACRILEX
002	TROCHE/LOZENGE;ORAL	EQ 4MG BASE	0	NICOTINE POLACRILEX	NICOTINE POLACRILEX

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

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
        )

)