ANDA 211224

ZYDUS WORLDWIDE DMCC

FDA Drug Application

Application #211224

Documents

• Letter: 2021-05-05

Application Sponsors

ANDA 211224

ZYDUS WORLDWIDE DMCC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

10MG

0

MACITENTAN

MACITENTAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-04-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS WORLDWIDE DMCC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211224
            [companyName] => ZYDUS WORLDWIDE DMCC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MACITENTAN","activeIngredients":"MACITENTAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/14\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-14
        )

)