ANDA 212408

BIONPHARMA INC

FDA Drug Application

Application #212408

Documents

• Letter: 2021-01-07

Application Sponsors

ANDA 212408

BIONPHARMA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

ENALAPRIL MALEATE

ENALAPRIL MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212408
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212408Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-28
        )

)