Application Sponsors
| ANDA 078211 | SUN PHARM INDS LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 12.5MG;EQ 10MG BASE | 0 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
| 002 | TABLET;ORAL | 12.5MG;EQ 20MG BASE | 0 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
| 003 | TABLET;ORAL | 25MG;EQ 20MG BASE | 0 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2009-03-04 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-12-02 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2014-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2015-12-04 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2015-12-04 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 78211
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"12.5MG;EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"12.5MG;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"25MG;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","actionType":"12.5MG;EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","actionType":"12.5MG;EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","actionType":"25MG;EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)