ANDA 215463

AUROBINDO PHARMA USA

FDA Drug Application

Application #215463

Documents

• Letter: 2022-08-04

Application Sponsors

ANDA 215463

AUROBINDO PHARMA USA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-02-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AUROBINDO PHARMA USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215463
            [companyName] => AUROBINDO PHARMA USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.6MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-03
        )

)