Documents
Application Sponsors
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 | 4 | AP | 2003-03-25 | |
LABELING; Labeling | SUPPL | 9 | AP | 2013-02-20 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2015-04-13 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2015-04-13 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2016-09-08 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2016-09-08 | STANDARD |
Submissions Property Types
SUPPL | 9 | Null | 15 |
SUPPL | 10 | Null | 15 |
SUPPL | 11 | Null | 15 |
SUPPL | 12 | Null | 7 |
SUPPL | 13 | Null | 7 |
CDER Filings
PHARMGEN
cder:Array
(
[0] => Array
(
[ApplNo] => 75999
[companyName] => PHARMGEN
[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
)
)