ANDA 206002

ALVOGEN PINE BROOK

FDA Drug Application

Application #206002

Application Sponsors

ANDA 206002

ALVOGEN PINE BROOK

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-26	STANDARD
REMS; REMS	SUPPL	3	AP	2022-04-29

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

ALVOGEN PINE BROOK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206002
            [companyName] => ALVOGEN PINE BROOK
            [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":"04\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-26
        )

)