Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | TABLET;ORAL | EQ 5MG BASE;12.5MG;160MG | 0 | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
| 002 | TABLET;ORAL | EQ 5MG BASE;25MG;160MG | 0 | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
| 003 | TABLET;ORAL | EQ 10MG BASE;12.5MG;160MG | 0 | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
| 004 | TABLET;ORAL | EQ 10MG BASE;25MG;160MG | 0 | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
| 005 | TABLET;ORAL | EQ 10MG BASE;25MG;320MG | 0 | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2015-06-01 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-04-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
PAR PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 201087
[companyName] => PAR PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 5MG BASE;12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 5MG BASE;25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;25MG;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/01\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/05\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/05\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/05\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-04-05
)
)