ANDA 206194

HISUN PHARM HANGZHOU

FDA Drug Application

Application #206194

Application Sponsors

ANDA 206194

HISUN PHARM HANGZHOU

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	75MG	0	IRBESARTAN	IRBESARTAN
002	TABLET;ORAL	150MG	0	IRBESARTAN	IRBESARTAN
003	TABLET;ORAL	300MG	0	IRBESARTAN	IRBESARTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

HISUN PHARM HANGZHOU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206194
            [companyName] => HISUN PHARM HANGZHOU
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-02
        )

)