Application Sponsors
| NDA 017637 | ICU MEDICAL INC | |
Marketing Status
Application Products
| 002 | SOLUTION;IRRIGATION | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | 0 | PHYSIOSOL IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1978-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1978-09-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1978-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1978-08-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1978-09-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1978-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1978-11-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1978-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1979-04-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1979-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1979-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1979-07-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1979-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1979-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1980-03-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1981-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1980-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1980-06-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1980-06-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1980-09-08 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 1980-10-01 | |
| LABELING; Labeling | SUPPL | 25 | AP | 1982-07-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1981-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1982-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1984-03-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1982-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1984-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1984-08-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1984-10-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1984-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1986-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1985-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1986-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1988-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1993-08-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1992-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1996-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 1998-05-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1998-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2000-02-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1999-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2014-06-12 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | 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 | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 61 | Null | 0 |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 17637
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"PHYSIOSOL IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","strength":"30MG\/100ML;37MG\/100ML;222MG\/100ML;526MG\/100ML;502MG\/100ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PHYSIOSOL IN PLASTIC CONTAINER","submission":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","actionType":"30MG\/100ML;37MG\/100ML;222MG\/100ML;526MG\/100ML;502MG\/100ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)