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
)
)