Application Sponsors
ANDA 090654 | SUN PHARM INDS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 25MG;50MG | 0 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
002 | TABLET;ORAL | 25MG;100MG | 0 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
003 | TABLET;ORAL | 50MG;100MG | 0 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 90654
[companyName] => SUN PHARM INDS
[docInserts] => ["",""]
[products] => [{"drugName":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","strength":"25MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","strength":"50MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","actionType":"25MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","actionType":"25MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","actionType":"50MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)