Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 25MG;37.5MG | 0 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE |
FDA Submissions
| ORIG | 1 | AP | 1996-04-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-07-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-05-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-05-29 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 74026
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","actionType":"25MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)