Application Sponsors
ANDA 201011 | NOSTRUM LABS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | SOLUTION;ORAL | 10MG/5ML | 0 | MORPHINE SULFATE | MORPHINE SULFATE |
002 | SOLUTION;ORAL | 20MG/5ML | 0 | MORPHINE SULFATE | MORPHINE SULFATE |
003 | SOLUTION;ORAL | 100MG/5ML | 0 | MORPHINE SULFATE | MORPHINE SULFATE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2014-02-05 | |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
003 | Prescription | AA |
CDER Filings
NOSTRUM LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 201011
[companyName] => NOSTRUM LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"20MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/05\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-1","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-09-18
)
)