ANDA 215762

ANNORA PHARMA

FDA Drug Application

Application #215762

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 215762

ANNORA PHARMA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215762
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLCHICINE","activeIngredients":"COLCHICINE","strength":"0.6MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-15
        )

)