Application Sponsors
ANDA 090228 | INVAGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 10MG;12.5MG | 0 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE |
002 | TABLET;ORAL | 20MG;12.5MG | 0 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 2009-07-09 | |
LABELING; Labeling | SUPPL | 2 | AP | 2015-09-14 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2015-09-14 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 9 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 90228
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"10MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"20MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"10MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"20MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)