ANDA 076007

SUN PHARM INDS LTD

FDA Drug Application

Application #076007

Documents

• Letter: 2003-04-10
• Letter: 2004-06-08

Application Sponsors

ANDA 076007

SUN PHARM INDS LTD

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	2002-07-01
LABELING; Labeling	SUPPL	10	AP	2009-09-02
LABELING; Labeling	SUPPL	12	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-02-28	STANDARD

Submissions Property Types

SUPPL	10	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76007
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"25MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"25MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)