ANDA 076063

HIKMA INTL PHARMS

FDA Drug Application

Application #076063

Application Sponsors

ANDA 076063

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	TABLET;ORAL	2.5MG	0	LISINOPRIL	LISINOPRIL
002	TABLET;ORAL	5MG	0	LISINOPRIL	LISINOPRIL
003	TABLET;ORAL	10MG	0	LISINOPRIL	LISINOPRIL
004	TABLET;ORAL	20MG	0	LISINOPRIL	LISINOPRIL
005	TABLET;ORAL	40MG	0	LISINOPRIL	LISINOPRIL
006	TABLET;ORAL	30MG	0	LISINOPRIL	LISINOPRIL

FDA Submissions

	ORIG	1	AP	2002-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2003-06-27
LABELING; Labeling	SUPPL	3	AP	2003-06-27
LABELING; Labeling	SUPPL	11	AP	2006-03-13
LABELING; Labeling	SUPPL	13	AP	2006-03-13
LABELING; Labeling	SUPPL	19	AP	2007-02-16
LABELING; Labeling	SUPPL	29	AP	2007-06-25
LABELING; Labeling	SUPPL	31	AP	2009-08-21
LABELING; Labeling	SUPPL	33	AP	2008-01-28
LABELING; Labeling	SUPPL	35	AP	2009-09-10
LABELING; Labeling	SUPPL	38	AP	2010-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2013-08-05
LABELING; Labeling	SUPPL	42	AP	2013-02-28
LABELING; Labeling	SUPPL	45	AP	2013-02-28	STANDARD
LABELING; Labeling	SUPPL	47	AP	2013-02-28	STANDARD
LABELING; Labeling	SUPPL	48	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	49	AP	2013-08-14	STANDARD
LABELING; Labeling	SUPPL	51	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	53	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	54	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	55	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	56	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	57	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	60	AP	2016-09-15	STANDARD
LABELING; Labeling	SUPPL	61	AP	2016-09-15	STANDARD
LABELING; Labeling	SUPPL	63	AP	2016-09-15	STANDARD
LABELING; Labeling	SUPPL	64	AP	2016-09-15	STANDARD
LABELING; Labeling	SUPPL	65	AP	2020-05-13	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	31	Null	42
SUPPL	35	Null	7
SUPPL	38	Null	7
SUPPL	40	Null	15
SUPPL	42	Null	15
SUPPL	45	Null	15
SUPPL	47	Null	15
SUPPL	48	Null	7
SUPPL	49	Null	15
SUPPL	51	Null	15
SUPPL	53	Null	15
SUPPL	54	Null	7
SUPPL	55	Null	7
SUPPL	56	Null	7
SUPPL	57	Null	15
SUPPL	60	Null	7
SUPPL	61	Null	7
SUPPL	63	Null	7
SUPPL	64	Null	7
SUPPL	65	Null	15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76063
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)