Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | 1 | K-TAB | POTASSIUM CHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 8MEQ | 1 | K-TAB | POTASSIUM CHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 20MEQ | 1 | K-TAB | POTASSIUM CHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1980-06-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1981-02-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1981-01-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1981-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1982-11-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-07-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1984-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1984-08-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1985-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1986-01-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1986-06-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1988-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1988-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1989-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-03-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1993-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1996-11-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2002-10-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2002-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2004-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2012-02-15 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2014-09-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2013-08-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2014-06-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2013-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2014-06-26 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2018-04-30 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 37 | Null | 7 |
TE Codes
| 001 | Prescription | AB3 |
| 002 | Prescription | BC |
| 003 | Prescription | AB3 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 18279
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"K-TAB","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"K-TAB","activeIngredients":"POTASSIUM CHLORIDE","strength":"8MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"K-TAB","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/30\/2018","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018279Orig1s037lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2014","submission":"SUPPL-34","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018279s034lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/25\/2013","submission":"SUPPL-33","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018279s033lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
[originalApprovals] => [{"actionDate":"K-TAB","submission":"POTASSIUM CHLORIDE","actionType":"10MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"K-TAB","submission":"POTASSIUM CHLORIDE","actionType":"8MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"K-TAB","submission":"POTASSIUM CHLORIDE","actionType":"20MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-04-30
)
)