Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 100MG/5ML | 0 | MORPHINE SULFATE | MORPHINE SULFATE |
FDA Submissions
| ORIG | 1 | AP | 2011-07-15 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-02-24 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-02-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 7 |
TE Codes
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 202348
[companyName] => SPECGX LLC
[docInserts] => ["",""]
[products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/15\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-6","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/04\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-24
)
)