Application Sponsors
ANDA 077222 | INVAGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM |
002 | TABLET;ORAL | 20MG | 0 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM |
003 | TABLET;ORAL | 40MG | 0 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2005-04-20 | |
LABELING; Labeling | SUPPL | 5 | AP | 2016-01-26 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2016-01-26 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 77222
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)