ANDA 216236

SANDOZ INC

FDA Drug Application

Application #216236

Documents

• Letter: 2022-08-30

Application Sponsors

ANDA 216236

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

40MG

0

NERATINIB MALEATE

NERATINIB MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-07-05

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216236
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NERATINIB MALEATE","activeIngredients":"NERATINIB MALEATE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/05\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-05
        )

)