ANDA 075944

SUN PHARM INDS LTD

FDA Drug Application

Application #075944

Documents

• Letter: 2004-06-24

Application Sponsors

ANDA 075944

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 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
LABELING; Labeling	SUPPL	2	AP	2003-02-11
LABELING; Labeling	SUPPL	12	AP	2007-09-24
LABELING; Labeling	SUPPL	17	AP	2010-02-22
LABELING; Labeling	SUPPL	18	AP	2010-03-08
LABELING; Labeling	SUPPL	19	AP	2010-03-12
LABELING; Labeling	SUPPL	20	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	21	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	22	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	23	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	24	AP	2015-08-25	STANDARD
LABELING; Labeling	SUPPL	25	AP	2015-08-25	STANDARD
LABELING; Labeling	SUPPL	26	AP	2015-08-25	STANDARD
LABELING; Labeling	SUPPL	27	AP	2015-11-25	STANDARD
LABELING; Labeling	SUPPL	28	AP	2016-09-16	STANDARD
LABELING; Labeling	SUPPL	29	AP	2020-04-27	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75944
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)