NDA 012487

ROCHE

FDA Drug Application

Application #012487

Application Sponsors

NDA 012487

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

12.5MG/ML

0

TARACTAN

CHLORPROTHIXENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1962-03-23	STANDARD
LABELING; Labeling	SUPPL	12	AP	1974-06-16
LABELING; Labeling	SUPPL	14	AP	1997-06-25
LABELING; Labeling	SUPPL	17	AP	1979-01-08
LABELING; Labeling	SUPPL	18	AP	1997-06-25
LABELING; Labeling	SUPPL	19	AP	1981-01-29
LABELING; Labeling	SUPPL	20	AP	1997-06-25
LABELING; Labeling	SUPPL	21	AP	1984-09-27
LABELING; Labeling	SUPPL	23	AP	1997-06-25
LABELING; Labeling	SUPPL	24	AP	1997-06-25
LABELING; Labeling	SUPPL	25	AP	1997-06-25

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12487
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"12.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"12.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)