Documents
Application Sponsors
ANDA 075621 | BEXIMCO PHARMS USA | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | TABLET;ORAL | 2.5MG | 0 | ENALAPRIL MALEATE | ENALAPRIL MALEATE |
002 | TABLET;ORAL | 5MG | 0 | ENALAPRIL MALEATE | ENALAPRIL MALEATE |
003 | TABLET;ORAL | 10MG | 0 | ENALAPRIL MALEATE | ENALAPRIL MALEATE |
004 | TABLET;ORAL | 20MG | 0 | ENALAPRIL MALEATE | ENALAPRIL MALEATE |
FDA Submissions
| ORIG | 1 | AP | 2000-08-22 | |
LABELING; Labeling | SUPPL | 2 | AP | 2002-08-22 | |
CDER Filings
BEXIMCO PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 75621
[companyName] => BEXIMCO PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)