Documents
Application Sponsors
| NDA 019492 | ICU MEDICAL INC | |
Marketing Status
Application Products
| 002 | INJECTABLE;INJECTION | 10% (10GM/100ML) | 0 | AMINOSYN-PF 10% | AMINO ACIDS |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1986-10-17 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1987-11-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1987-10-20 | |
| 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 | 1990-12-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1992-09-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1994-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1999-06-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-09-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-10-25 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | 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 | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19492
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMINOSYN-PF 10%","activeIngredients":"AMINO ACIDS","strength":"10% (10GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMINOSYN-PF 10%","submission":"AMINO ACIDS","actionType":"10% (10GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)