ANDA 203508

INVAGEN PHARMS

FDA Drug Application

Application #203508

Application Sponsors

ANDA 203508

INVAGEN PHARMS

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

UNKNOWN;	ORIG	1	AP	2013-10-29
LABELING; Labeling	SUPPL	2	AP	2015-06-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-06-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-09-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-09-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	15	Null	15

TE Codes

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

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203508
            [companyName] => INVAGEN PHARMS
            [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":"10\/29\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/17\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/17\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/18\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/02\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/02\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-17
        )

)