Documents
Application Sponsors
| NDA 204223 | FRESENIUS KABI USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 2MG/ML (2MG/ML) | 1 | MORPHINE SULFATE | MORPHINE SULFATE |
| 002 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 4MG/ML (4MG/ML) | 1 | MORPHINE SULFATE | MORPHINE SULFATE |
| 003 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5MG/ML (5MG/ML) | 1 | MORPHINE SULFATE | MORPHINE SULFATE |
| 004 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 8MG/ML (8MG/ML) | 1 | MORPHINE SULFATE | MORPHINE SULFATE |
| 005 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 10MG/ML (10MG/ML) | 1 | MORPHINE SULFATE | MORPHINE SULFATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2013-10-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-11-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2015-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-01-27 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-10-07 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 15 | Null | 7 |
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 204223
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"2MG\/ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"4MG\/ML (4MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"5MG\/ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"8MG\/ML (8MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204223s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204223s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204223s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204223s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204223s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/30\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204223s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204223Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204223Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204223Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204223s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204223Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204223s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204223Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/16\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-07
)
)