Documents
Application Sponsors
| ANDA 077419 | ACTAVIS LABS FL INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 8MEQ | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 10MEQ | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2008-06-02 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2010-11-22 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2013-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-06-10 | STANDARD |
Submissions Property Types
| SUPPL | 15 | Null | 15 |
| SUPPL | 18 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ACTAVIS LABS FL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 77419
[companyName] => ACTAVIS LABS FL INC
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"8MEQ","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] => [{"actionDate":"06\/02\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/077419lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"8MEQ","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"10MEQ","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2008-06-02
)
)