Application Sponsors
ANDA 089441 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 100MG EXTENDED | 0 | EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1986-12-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-05-11 | |
LABELING; Labeling | SUPPL | 3 | AP | 1999-02-03 | |
LABELING; Labeling | SUPPL | 5 | AP | 1999-10-19 | |
Submissions Property Types
CDER Filings
ANI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 89441
[companyName] => ANI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"EXTENDED PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"100MG EXTENDED","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"EXTENDED PHENYTOIN SODIUM","submission":"PHENYTOIN SODIUM","actionType":"100MG EXTENDED","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)