Application Sponsors
| ANDA 202230 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 25MG | 0 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM |
| 002 | TABLET;ORAL | 50MG | 0 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM |
| 003 | TABLET;ORAL | 100MG | 0 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-05-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-05-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 10 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202230
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/30\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/21\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/09\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/12\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/28\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-21
)
)