ANDA 207455

PRINSTON INC

FDA Drug Application

Application #207455

Application Sponsors

ANDA 207455

PRINSTON INC

Marketing Status

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

Application Products

001	TABLET;ORAL	16MG;12.5MG	0	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	32MG;12.5MG	0	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
003	TABLET;ORAL	32MG;25MG	0	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207455
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"16MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"32MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"32MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-11
        )

)