ANDA 215444

AUROBINDO PHARMA LTD

FDA Drug Application

Application #215444

Application Sponsors

ANDA 215444

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.6MG

0

COLCHICINE

COLCHICINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215444
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COLCHICINE","submission":"COLCHICINE","actionType":"0.6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)