ANDA 091524

APOTEX CORP

FDA Drug Application

Application #091524

Application Sponsors

ANDA 091524

APOTEX CORP

Marketing Status

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

Application Products

001	TABLET;ORAL	12.5MG;EQ 10MG BASE	0	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
002	TABLET;ORAL	12.5MG;EQ 20MG BASE	0	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
003	TABLET;ORAL	25MG;EQ 20MG BASE	0	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2013-03-12
LABELING; Labeling	SUPPL	2	AP	2014-11-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-11-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-11-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-02-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-05-27	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-05-27	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-05-27	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-05-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91524
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"12.5MG;EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"12.5MG;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"25MG;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","actionType":"12.5MG;EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","actionType":"12.5MG;EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","actionType":"25MG;EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)