ANDA 075903

INVATECH

FDA Drug Application

Application #075903

Application Sponsors

ANDA 075903

INVATECH

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 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	14	AP	2007-02-13
LABELING; Labeling	SUPPL	15	AP	2006-07-03
LABELING; Labeling	SUPPL	17	AP	2009-12-01
LABELING; Labeling	SUPPL	18	AP	2009-12-01
LABELING; Labeling	SUPPL	19	AP	2010-05-07
LABELING; Labeling	SUPPL	20	AP	2020-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2021-08-17	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2021-12-23	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	23	Null	15

TE Codes

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

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75903
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)