ANDA 210921

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210921

Application Sponsors

ANDA 210921

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	8MEQ	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	10MEQ	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB2
002	Prescription	AB2

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210921
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"8MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-19
        )

)