ANDA 203007

NATCO PHARMA LTD

FDA Drug Application

Application #203007

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 203007

NATCO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

250MG

0

LAPATINIB

LAPATINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-09-18

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203007
            [companyName] => NATCO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAPATINIB","activeIngredients":"LAPATINIB","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/18\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-18
        )

)