Application Sponsors
| NDA 017656 | ICU MEDICAL INC | |
Marketing Status
Application Products
| 001 | SOLUTION;IRRIGATION, URETHRAL | 250MG/100ML | 1 | ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1976-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1977-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1977-05-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1978-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1978-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1978-11-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1979-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1979-01-26 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1979-02-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1979-07-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1979-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1979-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1980-03-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1981-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1980-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1980-06-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1980-06-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1980-09-08 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 1980-10-01 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1982-06-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1981-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1982-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1984-03-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1984-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1984-08-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1984-10-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1986-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1985-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1988-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1993-08-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1992-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1996-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 1997-11-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1998-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2000-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2014-06-12 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 51 | Null | 0 |
TE Codes
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 17656
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"ACETIC ACID 0.25% IN PLASTIC CONTAINER","activeIngredients":"ACETIC ACID, GLACIAL","strength":"250MG\/100ML","dosageForm":"SOLUTION;IRRIGATION, URETHRAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACETIC ACID 0.25% IN PLASTIC CONTAINER","submission":"ACETIC ACID, GLACIAL","actionType":"250MG\/100ML","submissionClassification":"SOLUTION;IRRIGATION, URETHRAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)