ANDA 081310

ANI PHARMS INC

FDA Drug Application

Application #081310

Application Sponsors

ANDA 081310

ANI PHARMS INC

Marketing Status

• Discontinued: 001

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
        )

)