ANDA 205823

PRINSTON INC

FDA Drug Application

Application #205823

Application Sponsors

ANDA 205823

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE
002	TABLET;ORAL	EQ 10MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE
003	TABLET;ORAL	EQ 20MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE
004	TABLET;ORAL	EQ 40MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-09-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-11-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205823
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/01\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-01
        )

)