Application Sponsors
ANDA 040857 | SUN PHARM INDS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 12.5MG | 0 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 2008-05-30 | |
LABELING; Labeling | SUPPL | 7 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 40857
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)