Application Sponsors
ANDA 090544 | UPSHER SMITH LABS | |
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 | 2010-10-06 | |
LABELING; Labeling | SUPPL | 4 | AP | 2012-12-17 | |
LABELING; Labeling | SUPPL | 6 | AP | 2015-10-14 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2015-10-14 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2015-10-14 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 4 | Null | 7 |
SUPPL | 6 | Null | 7 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
UPSHER SMITH LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 90544
[companyName] => UPSHER SMITH 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
)
)