Application Sponsors
| ANDA 203562 | GLENMARK PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 20MEQ | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-07-26 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2021-02-26 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
TE Codes
| 001 | Prescription | AB1 |
| 002 | Prescription | AB1 |
CDER Filings
GLENMARK PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203562
[companyName] => GLENMARK PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-07-26
)
)