Application Sponsors
| NDA 019416 | ICU MEDICAL INC | |
Marketing Status
Application Products
| 001 | SOLUTION;IRRIGATION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | 1 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1986-01-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-08-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-11-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1989-06-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1989-06-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1990-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1990-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1991-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1992-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1999-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1997-06-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1997-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2014-08-15 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 32 | Null | 0 |
TE Codes
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19416
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"LACTATED RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"20MG\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LACTATED RINGER'S IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"20MG\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)