NDA 016149

ROCHE

FDA Drug Application

Application #016149

Application Sponsors

NDA 016149

ROCHE

Marketing Status

• Discontinued: 002

Application Products

002

CONCENTRATE;ORAL

100MG/5ML

0

TARACTAN

CHLORPROTHIXENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1967-06-19	STANDARD
LABELING; Labeling	SUPPL	13	AP	1974-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1976-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1979-05-04	STANDARD
LABELING; Labeling	SUPPL	21	AP	1979-01-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1979-01-10	STANDARD
LABELING; Labeling	SUPPL	24	AP	1981-01-29	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	13	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16149
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"100MG\/5ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"100MG\/5ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)