Application Sponsors
| ANDA 077483 | SUN PHARM INDS LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 5MG;6.25MG | 0 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
| 002 | TABLET;ORAL | 10MG;12.5MG | 0 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
| 003 | TABLET;ORAL | 20MG;12.5MG | 0 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
| 004 | TABLET;ORAL | 20MG;25MG | 0 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 2005-09-08 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-09-23 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2014-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2015-04-06 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2016-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-11-07 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-11-07 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 77483
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","strength":"5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","strength":"10MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","strength":"20MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","strength":"20MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","actionType":"5MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","actionType":"10MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","actionType":"20MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","actionType":"20MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)