Documents
Application Sponsors
| NDA 017789 | ICU MEDICAL INC | |
Marketing Status
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
Application Products
| 002 | INJECTABLE;INJECTION | 7%;102MG/100ML;522MG/100ML;410MG/100ML | 0 | AMINOSYN 7% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE |
| 003 | INJECTABLE;INJECTION | 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML | 0 | AMINOSYN 3.5% M | AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE |
| 004 | INJECTABLE;INJECTION | 3.5% (3.5GM/100ML) | 0 | AMINOSYN 3.5% | AMINO ACIDS |
| 005 | INJECTABLE;INJECTION | 3.5%;21MG/100ML;128MG/100ML;234MG/100ML | 0 | AMINOSYN 3.5% M | AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1976-05-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1978-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1977-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1977-04-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1977-07-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1978-05-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1978-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1979-01-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1979-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1979-03-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1979-05-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1979-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1979-02-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1979-02-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1978-12-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1980-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1980-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1979-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1979-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 1980-07-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1980-06-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1981-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1981-05-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1981-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1981-02-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1981-09-15 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 1981-09-15 | |
| LABELING; Labeling | SUPPL | 31 | AP | 1981-12-07 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1984-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1982-06-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1983-10-13 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 1983-10-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1983-07-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1983-07-05 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 1984-10-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1985-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1986-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 1987-07-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1992-02-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1992-08-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1993-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1994-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1997-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1999-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2003-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2002-10-25 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | 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 | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 52 | Null | 0 |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 17789
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMINOSYN 3.5%","activeIngredients":"AMINO ACIDS","strength":"3.5% (3.5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 3.5% M","activeIngredients":"AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE","strength":"3.5%;21MG\/100ML;40MG\/100ML;128MG\/100ML;234MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 3.5% M","activeIngredients":"AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE","strength":"3.5%;21MG\/100ML;128MG\/100ML;234MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 7% W\/ ELECTROLYTES","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","strength":"7%;102MG\/100ML;522MG\/100ML;410MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMINOSYN 3.5%","submission":"AMINO ACIDS","actionType":"3.5% (3.5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 3.5% M","submission":"AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE","actionType":"3.5%;21MG\/100ML;40MG\/100ML;128MG\/100ML;234MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 3.5% M","submission":"AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE","actionType":"3.5%;21MG\/100ML;128MG\/100ML;234MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 7% W\/ ELECTROLYTES","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","actionType":"7%;102MG\/100ML;522MG\/100ML;410MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)