ANDA 076344

SUN PHARM INDS LTD

FDA Drug Application

Application #076344

Documents

• Letter: 2004-02-12

Application Sponsors

ANDA 076344

SUN PHARM INDS LTD

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	2004-02-11
LABELING; Labeling	SUPPL	8	AP	2007-06-27
LABELING; Labeling	SUPPL	11	AP	2012-11-08
LABELING; Labeling	SUPPL	12	AP	2012-11-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	17	AP	2017-12-14	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-06-24	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7

TE Codes

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

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76344
            [companyName] => SUN PHARM INDS LTD
            [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
        )

)