Application Sponsors
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
| ORIG | 1 | AP | 2012-09-24 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-05-07 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 12 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MICRO LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 91541
[companyName] => MICRO LABS
[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":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)