Application Sponsors
ANDA 081310 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | ELIXIR;ORAL | 2.5MG/5ML | 0 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1993-04-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-05-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-05-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-06-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-03-23 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 81310
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"2.5MG\/5ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"2.5MG\/5ML","submissionClassification":"ELIXIR;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)