Application Sponsors
ANDA 211797 | GRANULES PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 8MEQ | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
002 | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-03-04 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB2 |
002 | Prescription | AB2 |
CDER Filings
GRANULES PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 211797
[companyName] => GRANULES PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"8MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-03-04
)
)