ANDA 213154

NATCO PHARMA LTD

FDA Drug Application

Application #213154

Documents

• Letter: 2021-05-05

Application Sponsors

ANDA 213154

NATCO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

UNKNOWN

UNKNOWN

0

BOSENTAN

BOSENTAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213154
            [companyName] => NATCO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/01\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-01
        )

)