ANDA 210969

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210969

Application Sponsors

ANDA 210969

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

1GM/100ML (10MG/ML)

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210969
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)