ANDA 203072

PRINSTON INC

FDA Drug Application

Application #203072

Application Sponsors

ANDA 203072

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002
• None (Tentative Approval): 003

Application Products

001	TABLET;ORAL	12.5MG;150MG	0	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
002	TABLET;ORAL	12.5MG;300MG	0	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
003	TABLET;ORAL	25MG/300MG	0	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-05-09
UNKNOWN;	ORIG	2	TA	2014-05-09
LABELING; Labeling	SUPPL	5	AP	2020-06-02	STANDARD

Submissions Property Types

ORIG	1	Null	1
ORIG	2	Null	1
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203072
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"25MG\/300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/09\/2014","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/09\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/02\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-02
        )

)