Application Sponsors
| NDA 020161 | ICU MEDICAL INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
Application Products
| 001 | INJECTABLE;INJECTION | 745MG/100ML | 1 | POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE |
| 002 | INJECTABLE;INJECTION | 1.49GM/100ML | 1 | POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE |
| 003 | INJECTABLE;INJECTION | 2.24GM/100ML | 1 | POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE |
| 004 | INJECTABLE;INJECTION | 2.98GM/100ML | 1 | POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE |
| 005 | INJECTABLE;INJECTION | 14.9MG/ML | 1 | POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE |
| 006 | INJECTABLE;INJECTION | 29.8MG/ML | 1 | POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1992-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1994-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1999-09-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1998-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-11-01 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
| 004 | Prescription | AP |
| 005 | Prescription | AP |
| 006 | Prescription | AP |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20161
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE","strength":"745MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE","strength":"14.9MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE","strength":"1.49GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE","strength":"29.8MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE","strength":"2.24GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE","strength":"2.98GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE","actionType":"745MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE","actionType":"14.9MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE","actionType":"1.49GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE","actionType":"29.8MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE","actionType":"2.24GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE","actionType":"2.98GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)