Application Sponsors
| ANDA 210041 | AMNEAL PHARMS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;ORAL | 20MEQ/15ML | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
| 002 | SOLUTION;ORAL | 40MEQ/15ML | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-07-19 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2022-12-19 | UNKNOWN |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 6 | Null | 7 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
AMNEAL
cder:Array
(
[0] => Array
(
[ApplNo] => 210041
[companyName] => AMNEAL
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"40MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/16\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-16
)
)