Documents
Application Sponsors
| NDA 019916 | ICU MEDICAL INC | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 1MG/ML | 1 | MORPHINE SULFATE | MORPHINE SULFATE |
| 002 | INJECTABLE;INJECTION | 5MG/ML | 1 | MORPHINE SULFATE | MORPHINE SULFATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1992-10-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2006-10-27 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2008-03-18 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2016-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2019-10-07 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 19 | Null | 15 |
TE Codes
CDER Filings
ICU MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19916
[companyName] => ICU MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019916s019,019917s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2006","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019916s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2006","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019916s004lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-10-07
)
)