Application Sponsors
| NDA 017513 | ICU MEDICAL INC | |
Marketing Status
Application Products
| 001 | LIQUID;IRRIGATION | 100% | 0 | STERILE WATER IN PLASTIC CONTAINER | STERILE WATER FOR IRRIGATION |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1974-04-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1975-07-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1975-09-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1975-07-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1975-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1976-03-29 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1976-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1977-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1977-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1977-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1978-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1978-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1978-10-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1978-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1978-11-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1978-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1979-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1979-01-03 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1979-04-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1979-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1979-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1979-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1980-03-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1981-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1980-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1980-06-06 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1980-10-06 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1980-10-01 | |
| LABELING; Labeling | SUPPL | 33 | AP | 1982-08-26 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1981-03-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1981-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1982-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1984-03-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1984-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1984-08-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1984-10-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1986-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1986-11-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1985-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1988-11-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1993-08-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1992-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1998-02-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2014-09-24 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 61 | Null | 0 |
TE Codes
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 17513
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"STERILE WATER IN PLASTIC CONTAINER","activeIngredients":"STERILE WATER FOR IRRIGATION","strength":"100%","dosageForm":"LIQUID;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"STERILE WATER IN PLASTIC CONTAINER","submission":"STERILE WATER FOR IRRIGATION","actionType":"100%","submissionClassification":"LIQUID;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)