ANDA 077128

COREPHARMA

FDA Drug Application

Application #077128

Application Sponsors

ANDA 077128

COREPHARMA

Marketing Status

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

Application Products

001	TABLET;ORAL	5MG	0	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE
003	TABLET;ORAL	20MG	0	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE
004	TABLET;ORAL	40MG	0	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-03-08
LABELING; Labeling	SUPPL	2	AP	2008-04-29
LABELING; Labeling	SUPPL	4	AP	2009-01-21
LABELING; Labeling	SUPPL	6	AP	2010-11-30
LABELING; Labeling	SUPPL	7	AP	2012-11-08
LABELING; Labeling	SUPPL	8	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-05-01	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-05-01	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-01-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-12-14	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-04-02	STANDARD

Submissions Property Types

SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	15
SUPPL	15	Null	15

TE Codes

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

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77128
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENAZEPRIL HYDROCHLORIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENAZEPRIL HYDROCHLORIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENAZEPRIL HYDROCHLORIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENAZEPRIL HYDROCHLORIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENAZEPRIL HYDROCHLORIDE","submission":"BENAZEPRIL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BENAZEPRIL HYDROCHLORIDE","submission":"BENAZEPRIL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BENAZEPRIL HYDROCHLORIDE","submission":"BENAZEPRIL HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BENAZEPRIL HYDROCHLORIDE","submission":"BENAZEPRIL HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)