ANDA 214837

NATCO PHARMA LTD

FDA Drug Application

Application #214837

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 214837

NATCO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

1MG

0

TRABECTEDIN

TRABECTEDIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214837
            [companyName] => NATCO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRABECTEDIN","activeIngredients":"TRABECTEDIN","strength":"1MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-10
        )

)