Documents
Application Sponsors
| NDA 017673 | ICU MEDICAL INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
| Discontinued | 008 |
| Discontinued | 009 |
Application Products
| 001 | INJECTABLE;INJECTION | 5% (5GM/100ML) | 0 | AMINOSYN 5% | AMINO ACIDS |
| 002 | INJECTABLE;INJECTION | 7% (7GM/100ML) | 0 | AMINOSYN 7% | AMINO ACIDS |
| 003 | INJECTABLE;INJECTION | 10% (10GM/100ML) | 0 | AMINOSYN 10% | AMINO ACIDS |
| 004 | INJECTABLE;INJECTION | 8.5% (8.5GM/100ML) | 0 | AMINOSYN 8.5% | AMINO ACIDS |
| 005 | INJECTABLE;INJECTION | 8.5%;102MG/100ML;522MG/100ML;410MG/100ML | 0 | AMINOSYN 8.5% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE |
| 006 | INJECTABLE;INJECTION | 7% (7GM/100ML) | 0 | AMINOSYN 7% (PH6) | AMINO ACIDS |
| 007 | INJECTABLE;INJECTION | 8.5% (8.5GM/100ML) | 0 | AMINOSYN 8.5% (PH6) | AMINO ACIDS |
| 008 | INJECTABLE;INJECTION | 10% (10GM/100ML) | 0 | AMINOSYN 10% (PH6) | AMINO ACIDS |
| 009 | INJECTABLE;INJECTION | 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML | 0 | AMINOSYN 8.5% W/ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1975-12-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1978-07-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1976-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1976-08-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 1976-08-27 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1978-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1978-07-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1976-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1976-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1978-01-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1977-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1977-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1977-05-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1977-07-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1977-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1979-01-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1978-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1978-03-22 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1979-01-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1978-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1980-04-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1979-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1979-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1979-05-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1979-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 1979-09-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1979-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1979-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1980-07-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1981-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 1981-05-29 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1980-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1981-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1981-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 1985-04-10 | |
| LABELING; Labeling | SUPPL | 38 | AP | 1982-01-20 | |
| LABELING; Labeling | SUPPL | 39 | AP | 1982-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1982-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 1982-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1983-11-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1983-11-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1983-07-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1983-07-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1983-10-13 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 1984-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1985-03-11 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 1985-03-11 | |
| LABELING; Labeling | SUPPL | 50 | AP | 1985-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1985-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 1985-11-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1986-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 1987-07-13 | |
| LABELING; Labeling | SUPPL | 57 | AP | 1987-07-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1992-02-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1992-08-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 1993-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1994-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1996-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1997-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2003-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2002-10-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 2003-03-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 2004-03-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 89 | AP | 2013-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 90 | AP | 2016-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 91 | AP | 2016-07-28 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | 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 | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 67 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 89 | Null | 0 |
| SUPPL | 90 | Null | 0 |
| SUPPL | 91 | Null | 0 |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 17673
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMINOSYN 10%","activeIngredients":"AMINO ACIDS","strength":"10% (10GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 10% (PH6)","activeIngredients":"AMINO ACIDS","strength":"10% (10GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 5%","activeIngredients":"AMINO ACIDS","strength":"5% (5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 7%","activeIngredients":"AMINO ACIDS","strength":"7% (7GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 7% (PH6)","activeIngredients":"AMINO ACIDS","strength":"7% (7GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 8.5%","activeIngredients":"AMINO ACIDS","strength":"8.5% (8.5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 8.5% (PH6)","activeIngredients":"AMINO ACIDS","strength":"8.5% (8.5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 8.5% W\/ ELECTROLYTES","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","strength":"8.5%;102MG\/100ML;522MG\/100ML;410MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 8.5% W\/ELECTROLYTES","activeIngredients":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC","strength":"8.5%;102MG\/100ML;487MG\/100ML;28MG\/100ML;425MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMINOSYN 10%","submission":"AMINO ACIDS","actionType":"10% (10GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 10% (PH6)","submission":"AMINO ACIDS","actionType":"10% (10GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 5%","submission":"AMINO ACIDS","actionType":"5% (5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 7%","submission":"AMINO ACIDS","actionType":"7% (7GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 7% (PH6)","submission":"AMINO ACIDS","actionType":"7% (7GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 8.5%","submission":"AMINO ACIDS","actionType":"8.5% (8.5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 8.5% (PH6)","submission":"AMINO ACIDS","actionType":"8.5% (8.5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 8.5% W\/ ELECTROLYTES","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","actionType":"8.5%;102MG\/100ML;522MG\/100ML;410MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 8.5% W\/ELECTROLYTES","submission":"AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC","actionType":"8.5%;102MG\/100ML;487MG\/100ML;28MG\/100ML;425MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)