Application Sponsors
| ANDA 202289 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 12.5MG;50MG | 0 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
| 002 | TABLET;ORAL | 12.5MG;100MG | 0 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
| 003 | TABLET;ORAL | 25MG;100MG | 0 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
FDA Submissions
| ORIG | 1 | AP | 2012-08-09 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-02-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 18 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202289
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"12.5MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"12.5MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/09\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/24\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/29\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/27\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-21
)
)