ANDA 076674

COREPHARMA

FDA Drug Application

Application #076674

Application Sponsors

ANDA 076674

COREPHARMA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2004-10-05
LABELING; Labeling	SUPPL	2	AP	2006-01-31
LABELING; Labeling	SUPPL	5	AP	2006-06-08
LABELING; Labeling	SUPPL	11	AP	2010-02-19
LABELING; Labeling	SUPPL	12	AP	2014-02-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-02-26	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-11-18	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-11-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-11-18	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-07-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	19	Null	31
SUPPL	20	Null	15

CDER Filings

COREPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76674
            [companyName] => COREPHARMA
            [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
        )

)