Application Sponsors
| NDA 019686 | ICU MEDICAL INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 149MG/100ML;900MG/100ML | 0 | POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 002 | INJECTABLE;INJECTION | 298MG/100ML;900MG/100ML | 0 | POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1988-10-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1990-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-08-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1999-05-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2014-09-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2015-09-10 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 32 | Null | 0 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19686
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"149MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"298MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"149MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"298MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)