ANDA 088477

WATSON LABS TEVA

FDA Drug Application

Application #088477

Application Sponsors

ANDA 088477

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

15MG

0

THIORIDAZINE HYDROCHLORIDE

THIORIDAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-04-30
LABELING; Labeling	SUPPL	10	AP	1991-01-15
LABELING; Labeling	SUPPL	16	AP	2015-11-03
LABELING; Labeling	SUPPL	17	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	16	Null	15
SUPPL	17	Null	15

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88477
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)