Application Sponsors
| ANDA 087535 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | 0 | METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE |
| 002 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE |
FDA Submissions
| ORIG | 1 | AP | 1982-06-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-04-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-04-12 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 87535
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)