Application Sponsors
| NDA 018362 | ICU MEDICAL INC | |
Marketing Status
| Prescription | 002 |
| Prescription | 003 |
| Discontinued | 004 |
| Prescription | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
| Discontinued | 008 |
| Prescription | 009 |
| Prescription | 010 |
Application Products
| 002 | INJECTABLE;INJECTION | 5GM/100ML;224MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 003 | INJECTABLE;INJECTION | 5GM/100ML;298MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 004 | INJECTABLE;INJECTION | 5GM/100ML;149MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 005 | INJECTABLE;INJECTION | 5GM/100ML;149MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 006 | INJECTABLE;INJECTION | 5GM/100ML;224MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 007 | INJECTABLE;INJECTION | 5GM/100ML;298MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 008 | INJECTABLE;INJECTION | 5GM/100ML;74.5MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 009 | INJECTABLE;INJECTION | 5GM/100ML;74.5MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
| 010 | INJECTABLE;INJECTION | 5GM/100ML;149MG/100ML;450MG/100ML | 1 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1980-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1980-09-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1981-01-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1981-04-08 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1981-04-08 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1981-06-12 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1981-07-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1981-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1982-06-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1982-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1982-02-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1982-07-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1982-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1983-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1984-03-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1982-07-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1984-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1984-10-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1984-02-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1983-12-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1983-07-05 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 1983-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1984-03-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1984-10-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1984-04-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1988-08-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1984-11-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1985-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1985-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1985-11-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1985-09-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1984-10-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1984-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1985-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1985-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 1985-10-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1986-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1985-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1986-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1986-08-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1986-11-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1988-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 1988-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1990-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1990-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1991-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1992-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1991-08-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1995-08-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1996-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1995-08-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1996-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1996-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 1997-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1997-06-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1998-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 1999-01-21 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 1999-05-27 | |
| LABELING; Labeling | SUPPL | 71 | AP | 2002-07-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 95 | AP | 2014-09-08 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | 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 | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 95 | Null | 0 |
TE Codes
| 002 | Prescription | AP |
| 003 | Prescription | AP |
| 005 | Prescription | AP |
| 009 | Prescription | AP |
| 010 | Prescription | AP |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 18362
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;149MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;74.5MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;224MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;298MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;149MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;224MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;298MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;149MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;74.5MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;149MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;74.5MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;224MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;298MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;149MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;224MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;298MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;149MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"5GM\/100ML;74.5MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)