Documents
Application Sponsors
| NDA 019437 | ICU MEDICAL INC | |
Marketing Status
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
| Discontinued | 008 |
Application Products
| 004 | INJECTABLE;INJECTION | 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML | 0 | AMINOSYN II 10% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE |
| 005 | INJECTABLE;INJECTION | 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML | 0 | AMINOSYN II 8.5% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE |
| 006 | INJECTABLE;INJECTION | 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML | 0 | AMINOSYN II 7% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE |
| 007 | INJECTABLE;INJECTION | 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML | 0 | AMINOSYN II 3.5% M | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE |
| 008 | INJECTABLE;INJECTION | 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML | 0 | AMINOSYN II 8.5% W/ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1986-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1986-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1988-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1992-02-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-08-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-09-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1993-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1999-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2003-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-10-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2013-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2016-06-06 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | 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 | 15 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 38 | Null | 0 |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19437
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMINOSYN II 10% W\/ ELECTROLYTES","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","strength":"10%;102MG\/100ML;45MG\/100ML;522MG\/100ML;410MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 3.5% M","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","strength":"3.5%;30MG\/100ML;97MG\/100ML;120MG\/100ML;49MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 7% W\/ ELECTROLYTES","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","strength":"7%;102MG\/100ML;45MG\/100ML;522MG\/100ML;410MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 8.5% W\/ ELECTROLYTES","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","strength":"8.5%;102MG\/100ML;45MG\/100ML;522MG\/100ML;410MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 8.5% W\/ELECTROLYTES","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC","strength":"8.5%;102MG\/100ML;492MG\/100ML;60MG\/100ML;425MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMINOSYN II 10% W\/ ELECTROLYTES","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","actionType":"10%;102MG\/100ML;45MG\/100ML;522MG\/100ML;410MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 3.5% M","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","actionType":"3.5%;30MG\/100ML;97MG\/100ML;120MG\/100ML;49MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 7% W\/ ELECTROLYTES","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","actionType":"7%;102MG\/100ML;45MG\/100ML;522MG\/100ML;410MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 8.5% W\/ ELECTROLYTES","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","actionType":"8.5%;102MG\/100ML;45MG\/100ML;522MG\/100ML;410MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 8.5% W\/ELECTROLYTES","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC","actionType":"8.5%;102MG\/100ML;492MG\/100ML;60MG\/100ML;425MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)