ANDA 210342

CIPLA

FDA Drug Application

Application #210342

Application Sponsors

ANDA 210342

CIPLA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	62.5MG	0	BOSENTAN	BOSENTAN
002	TABLET;ORAL	125MG	0	BOSENTAN	BOSENTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210342
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"62.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-03
        )

)