Application Sponsors
ANDA 076486 | NOSTRUM LABS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 5MG;12.5MG | 0 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
002 | TABLET;ORAL | 10MG;25MG | 0 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 2004-10-27 | |
LABELING; Labeling | SUPPL | 3 | AP | 2007-02-06 | |
LABELING; Labeling | SUPPL | 8 | AP | 2009-04-29 | |
LABELING; Labeling | SUPPL | 11 | AP | 2015-10-06 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2015-10-06 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2015-10-06 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2020-07-06 | STANDARD |
Submissions Property Types
SUPPL | 11 | Null | 7 |
SUPPL | 13 | Null | 7 |
SUPPL | 15 | Null | 15 |
SUPPL | 16 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
NOSTRUM LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 76486
[companyName] => NOSTRUM LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","strength":"5MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","strength":"10MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","submission":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","actionType":"5MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","submission":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","actionType":"10MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)