Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 50MG/ML | 0 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1987-03-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-06-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-11-30 | |
LABELING; Labeling | SUPPL | 11 | AP | 2014-01-29 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 11 | Null | 15 |
CDER Filings
HOSPIRA
cder:Array
(
[0] => Array
(
[ApplNo] => 89521
[companyName] => HOSPIRA
[docInserts] => ["",""]
[products] => [{"drugName":"PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PHENYTOIN SODIUM","submission":"PHENYTOIN SODIUM","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)