ANDA 078848

ZYDUS PHARMS USA

FDA Drug Application

Application #078848

Documents

• Other Important Information from FDA: 2008-05-30

Application Sponsors

ANDA 078848

ZYDUS PHARMS USA

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	2008-05-23
LABELING; Labeling	SUPPL	3	AP	2016-12-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-10-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-08-07	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15

TE Codes

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

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78848
            [companyName] => ZYDUS PHARMS USA
            [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
        )

)