NDA 016727

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #016727

Application Sponsors

NDA 016727

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

PROLIXIN DECANOATE

FLUPHENAZINE DECANOATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1972-06-20	STANDARD
S; Supplement	SUPPL	4	AP	1974-09-25	STANDARD
LABELING; Labeling	SUPPL	6	AP	2009-03-13
LABELING; Labeling	SUPPL	8	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1978-11-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	1979-02-06
LABELING; Labeling	SUPPL	11	AP	2009-03-13
LABELING; Labeling	SUPPL	14	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1980-01-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	1979-12-20
LABELING; Labeling	SUPPL	17	AP	1979-12-20
LABELING; Labeling	SUPPL	19	AP	1980-04-28
LABELING; Labeling	SUPPL	20	AP	1981-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1981-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1981-04-16	STANDARD
LABELING; Labeling	SUPPL	23	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1981-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1982-02-04	STANDARD
LABELING; Labeling	SUPPL	27	AP	1982-08-04
LABELING; Labeling	SUPPL	28	AP	1982-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1983-05-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1985-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1984-05-11	STANDARD
LABELING; Labeling	SUPPL	34	AP	1984-06-29
LABELING; Labeling	SUPPL	35	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1985-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1985-10-23	STANDARD
LABELING; Labeling	SUPPL	38	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1986-09-19	STANDARD
LABELING; Labeling	SUPPL	40	AP	2009-03-13
LABELING; Labeling	SUPPL	41	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1987-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1987-06-15	STANDARD
LABELING; Labeling	SUPPL	45	AP	2009-03-13
LABELING; Labeling	SUPPL	46	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1991-03-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1996-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1994-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1994-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2001-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	2002-10-04	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	9	Null	0
SUPPL	15	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16727
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROLIXIN DECANOATE","activeIngredients":"FLUPHENAZINE DECANOATE","strength":"25MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROLIXIN DECANOATE","submission":"FLUPHENAZINE DECANOATE","actionType":"25MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)