ANDA 076265

HIKMA INTL PHARMS

FDA Drug Application

Application #076265

Application Sponsors

ANDA 076265

HIKMA INTL PHARMS

Marketing Status

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

Application Products

001	TABLET;ORAL	12.5MG;10MG	0	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL
002	TABLET;ORAL	12.5MG;20MG	0	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL
003	TABLET;ORAL	25MG;20MG	0	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL

FDA Submissions

	ORIG	1	AP	2002-07-08
LABELING; Labeling	SUPPL	7	AP	2006-08-08
LABELING; Labeling	SUPPL	9	AP	2007-04-09
LABELING; Labeling	SUPPL	14	AP	2010-03-03
LABELING; Labeling	SUPPL	15	AP	2010-03-03
LABELING; Labeling	SUPPL	17	AP	2013-09-11
LABELING; Labeling	SUPPL	18	AP	2013-09-11
LABELING; Labeling	SUPPL	20	AP	2013-09-11	STANDARD
LABELING; Labeling	SUPPL	23	AP	2015-05-26	STANDARD
LABELING; Labeling	SUPPL	24	AP	2015-05-26	STANDARD
LABELING; Labeling	SUPPL	25	AP	2015-05-26	STANDARD
LABELING; Labeling	SUPPL	26	AP	2015-05-26	STANDARD
LABELING; Labeling	SUPPL	29	AP	2020-08-03	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-08-03	STANDARD
LABELING; Labeling	SUPPL	31	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	20	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76265
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"25MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"25MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)