Application Sponsors
| ANDA 083163 | INTL MEDICATION | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 2MEQ/ML | 0 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1975-08-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1987-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1987-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1991-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1991-02-07 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1991-04-04 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1992-06-15 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1992-03-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1993-02-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1993-08-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1993-10-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-01-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1996-06-18 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1996-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1995-09-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-06-18 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2022-12-02 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 7 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 83163
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)