ANDA 075743

PRINSTON INC

FDA Drug Application

Application #075743

Documents

• Letter: 2004-06-24

Application Sponsors

ANDA 075743

PRINSTON INC

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	30MG	0	LISINOPRIL	LISINOPRIL
006	TABLET;ORAL	40MG	0	LISINOPRIL	LISINOPRIL

FDA Submissions

	ORIG	1	AP	2002-07-01
LABELING; Labeling	SUPPL	6	AP	2004-10-29
LABELING; Labeling	SUPPL	7	AP	2005-08-30
LABELING; Labeling	SUPPL	9	AP	2006-01-23
LABELING; Labeling	SUPPL	10	AP	2008-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2016-02-24
LABELING; Labeling	SUPPL	14	AP	2014-12-11
LABELING; Labeling	SUPPL	15	AP	2014-12-11
LABELING; Labeling	SUPPL	18	AP	2014-12-11	STANDARD
LABELING; Labeling	SUPPL	19	AP	2014-12-11	STANDARD
LABELING; Labeling	SUPPL	20	AP	2014-12-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2014-12-11	STANDARD
LABELING; Labeling	SUPPL	24	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	30	AP	2016-09-08	STANDARD
LABELING; Labeling	SUPPL	32	AP	2020-04-27	STANDARD

Submissions Property Types

SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	29	Null	15
SUPPL	30	Null	15
SUPPL	32	Null	15

TE Codes

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

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75743
            [companyName] => PRINSTON INC
            [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":"30MG","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"}]
            [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":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)