ANDA 076102

COREPHARMA

FDA Drug Application

Application #076102

Application Sponsors

ANDA 076102

COREPHARMA

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	2002-09-30
LABELING; Labeling	SUPPL	5	AP	2006-06-08
LABELING; Labeling	SUPPL	6	AP	2008-08-22
LABELING; Labeling	SUPPL	10	AP	2013-08-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-07-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-07-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-07-13	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-07-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-07-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-04-29	STANDARD

Submissions Property Types

SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	15

TE Codes

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

CDER Filings

COREPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76102
            [companyName] => COREPHARMA
            [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
        )

)