ANDA 076118

PRINSTON INC

FDA Drug Application

Application #076118

Documents

• Letter: 2004-02-12

Application Sponsors

ANDA 076118

PRINSTON INC

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	9	AP	2007-09-25
LABELING; Labeling	SUPPL	13	AP	2008-08-22
LABELING; Labeling	SUPPL	15	AP	2008-10-20
LABELING; Labeling	SUPPL	16	AP	2010-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2010-10-26
LABELING; Labeling	SUPPL	18	AP	2012-11-08	STANDARD
LABELING; Labeling	SUPPL	19	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-11-12	STANDARD
LABELING; Labeling	SUPPL	21	AP	2015-11-12	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-07-06	STANDARD

Submissions Property Types

SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	7
SUPPL	24	Null	15

TE Codes

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

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76118
            [companyName] => PRINSTON INC
            [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
        )

)