Application Sponsors
| ANDA 202414 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| None (Tentative Approval) | 003 |
Application Products
| 001 | TABLET;ORAL | 12.5MG;150MG | 0 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN |
| 002 | TABLET;ORAL | 12.5MG;300MG | 0 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN |
| 003 | TABLET; ORAL | 300MG; 25MG | 0 | IRBESARTAN; HYDROCHLOROTHIAZIDE | IRBESARTAN: HYDROCHLOROTHIAZIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-09-27 | |
| UNKNOWN; | ORIG | 2 | TA | 2012-09-27 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-12-05 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2015-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2016-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2019-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2021-06-04 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2021-06-04 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2022-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2022-04-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| ORIG | 2 | Null | 42 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 12 | Null | 31 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 36 | Null | 15 |
| SUPPL | 43 | Null | 15 |
| SUPPL | 47 | Null | 7 |
| SUPPL | 49 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202414
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN; HYDROCHLOROTHIAZIDE","activeIngredients":"IRBESARTAN: HYDROCHLOROTHIAZIDE","strength":"300MG; 25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/27\/2012","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/02\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/02\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/18\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/05\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-02-02
)
)