Application Sponsors
ANDA 212678 | EDENBRIDGE PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 2.5MG;6.25MG | 0 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
002 | TABLET;ORAL | 5MG;6.25MG | 0 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
003 | TABLET;ORAL | 10MG;6.25MG | 0 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-07-09 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
EDENBRIDGE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 212678
[companyName] => EDENBRIDGE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"2.5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"10MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-07-09
)
)