ANDA 211123

SUN PHARM INDS

FDA Drug Application

Application #211123

Documents

• Letter: 2021-02-02

Application Sponsors

ANDA 211123

SUN PHARM INDS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

10MG

0

MACITENTAN

MACITENTAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-01-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SUN PHARM INDS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211123
            [companyName] => SUN PHARM INDS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MACITENTAN","activeIngredients":"MACITENTAN","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/25\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211123Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-25
        )

)