Application Sponsors
| NDA 019513 | ICU MEDICAL INC | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/100ML | 0 | IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1986-05-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-11-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1990-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1990-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1992-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-08-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1996-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2000-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1997-06-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1998-06-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2000-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2013-09-05 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 45 | Null | 0 |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19513
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS","strength":"5GM\/100ML;30MG\/100ML;141MG\/100ML;15MG\/100ML;260MG\/100ML;25MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS","actionType":"5GM\/100ML;30MG\/100ML;141MG\/100ML;15MG\/100ML;260MG\/100ML;25MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)