ANDA 076607

SUN PHARM INDS LTD

FDA Drug Application

Application #076607

Documents

• Letter: 2004-12-30

Application Sponsors

ANDA 076607

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE
002	TABLET;ORAL	EQ 10MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE
003	TABLET;ORAL	EQ 20MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE
004	TABLET;ORAL	EQ 40MG BASE	0	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-12-15
LABELING; Labeling	SUPPL	7	AP	2012-12-14
LABELING; Labeling	SUPPL	8	AP	2012-12-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-11-25	STANDARD

Submissions Property Types

SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76607
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)