Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | 0 | A-METHAPRED | METHYLPREDNISOLONE SODIUM SUCCINATE |
FDA Submissions
| ORIG | 1 | AP | 1987-08-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1991-08-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1990-11-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1990-11-20 | |
LABELING; Labeling | SUPPL | 5 | AP | 1990-01-10 | |
LABELING; Labeling | SUPPL | 6 | AP | 1992-01-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-10-30 | |
LABELING; Labeling | SUPPL | 9 | AP | 1993-10-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-02-04 | |
LABELING; Labeling | SUPPL | 11 | AP | 1994-03-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-05-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-10-23 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
CDER Filings
HOSPIRA
cder:Array
(
[0] => Array
(
[ApplNo] => 89173
[companyName] => HOSPIRA
[docInserts] => ["",""]
[products] => [{"drugName":"A-METHAPRED","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"A-METHAPRED","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)