Documents
Application Sponsors
| NDA 206814 | GENUS LIFESCIENCES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;ORAL | 20MEQ/15ML | 1 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
| 002 | SOLUTION;ORAL | 40MEQ/15ML | 1 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
FDA Submissions
| TYPE 7; Type 7 - Drug Already Marketed without Approved NDA | ORIG | 1 | AP | 2014-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-02-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2019-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-03-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 9 | Null | 6 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
GENUS LIFESCIENCES
cder:Array
(
[0] => Array
(
[ApplNo] => 206814
[companyName] => GENUS LIFESCIENCES
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"40MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206814s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2019","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206814s008lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"02\/04\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206814s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206814s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206814lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206814lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206814Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206814Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206814Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206814s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206814Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"05\/01\/2019","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206814s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206814Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"02\/04\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206814s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206814Orig1s007ltr_.pdf\"}]","notes":">"},{"actionDate":"07\/14\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-05
)
)