ANDA 211055

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211055

Application Sponsors

ANDA 211055

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

CARBIDOPA

CARBIDOPA

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211055
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA","activeIngredients":"CARBIDOPA","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-21
        )

)