ANDA 207628

AUROBINDO PHARMA LTD

FDA Drug Application

Application #207628

Application Sponsors

ANDA 207628

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.25% BASE

0

LEVALBUTEROL HYDROCHLORIDE

LEVALBUTEROL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-01-31	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AN

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207628
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVALBUTEROL HYDROCHLORIDE","activeIngredients":"LEVALBUTEROL HYDROCHLORIDE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/07\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-07
        )

)