NDA 012486

ROCHE

FDA Drug Application

Application #012486

Application Sponsors

NDA 012486

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	100MG	0	TARACTAN	CHLORPROTHIXENE
003	TABLET;ORAL	50MG	0	TARACTAN	CHLORPROTHIXENE
004	TABLET;ORAL	25MG	0	TARACTAN	CHLORPROTHIXENE
005	TABLET;ORAL	10MG	0	TARACTAN	CHLORPROTHIXENE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1962-05-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	1997-01-09
LABELING; Labeling	SUPPL	26	AP	1974-06-16
LABELING; Labeling	SUPPL	31	AP	1997-01-09
LABELING; Labeling	SUPPL	36	AP	1997-01-09
LABELING; Labeling	SUPPL	40	AP	1997-01-09
LABELING; Labeling	SUPPL	44	AP	1997-01-09
LABELING; Labeling	SUPPL	45	AP	1981-01-29
LABELING; Labeling	SUPPL	46	AP	1997-01-09
LABELING; Labeling	SUPPL	47	AP	1997-01-09
LABELING; Labeling	SUPPL	48	AP	1997-01-09
LABELING; Labeling	SUPPL	49	AP	1997-01-09

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12486
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)