ANDA 078457

INVAGEN PHARMS

FDA Drug Application

Application #078457

Documents

• Other Important Information from FDA: 2007-09-24

Application Sponsors

ANDA 078457

INVAGEN PHARMS

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

	ORIG	1	AP	2007-08-24
LABELING; Labeling	SUPPL	2	AP	2010-01-28
LABELING; Labeling	SUPPL	3	AP	2012-12-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-11-25	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-11-25	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-11-06	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	11	Null	15

TE Codes

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

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78457
            [companyName] => INVAGEN PHARMS
            [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":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)