ANDA 208695

HIKMA

FDA Drug Application

Application #208695

Application Sponsors

ANDA 208695

HIKMA

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	2019-04-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-11-06	STANDARD
REMS; REMS	SUPPL	3	AP	2022-04-29

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208695
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"62.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","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":"11\/06\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-06
        )

)