ANDA 088456

ANI PHARMS INC

FDA Drug Application

Application #088456

Application Sponsors

ANDA 088456

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

THIORIDAZINE HYDROCHLORIDE

THIORIDAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1994-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-02-16

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

CDER Filings

ANI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88456
            [companyName] => ANI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)