Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 016727
Company: BRISTOL MYERS SQUIBB

Products on NDA 016727

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROLIXIN DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016727

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/1972	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
10/04/2002	SUPPL-53	Manufacturing (CMC)	Label is not available on this site.
09/17/2001	SUPPL-52	Manufacturing (CMC)	Label is not available on this site.
08/16/1994	SUPPL-51	Manufacturing (CMC)-Packaging	Label is not available on this site.
08/11/1994	SUPPL-50	Manufacturing (CMC)-Control	Label is not available on this site.
02/15/1996	SUPPL-49	Manufacturing (CMC)	Label is not available on this site.
03/26/1991	SUPPL-48	Manufacturing (CMC)-Packaging	Label is not available on this site.
03/13/2009	SUPPL-46	Labeling	Label is not available on this site.
03/13/2009	SUPPL-45	Labeling	Label is not available on this site.
06/15/1987	SUPPL-43	Manufacturing (CMC)	Label is not available on this site.
06/15/1987	SUPPL-42	Manufacturing (CMC)-Packaging	Label is not available on this site.
03/13/2009	SUPPL-41	Labeling	Label is not available on this site.
03/13/2009	SUPPL-40	Labeling	Label is not available on this site.
09/19/1986	SUPPL-39	Manufacturing (CMC)	Label is not available on this site.
03/13/2009	SUPPL-38	Labeling	Label is not available on this site.
10/23/1985	SUPPL-37	Manufacturing (CMC)	Label is not available on this site.
02/12/1985	SUPPL-36	Manufacturing (CMC)-Packaging	Label is not available on this site.
03/13/2009	SUPPL-35	Labeling	Label is not available on this site.
06/29/1984	SUPPL-34	Labeling	Label is not available on this site.
05/11/1984	SUPPL-32	Manufacturing (CMC)-Packaging	Label is not available on this site.
12/21/1984	SUPPL-31	Manufacturing (CMC)-Control	Label is not available on this site.
05/30/1985	SUPPL-30	Manufacturing (CMC)	Label is not available on this site.
05/03/1983	SUPPL-29	Manufacturing (CMC)-Packaging	Label is not available on this site.
08/04/1982	SUPPL-28	Labeling	Label is not available on this site.
08/04/1982	SUPPL-27	Labeling	Label is not available on this site.
02/04/1982	SUPPL-26	Manufacturing (CMC)-Formulation	Label is not available on this site.
09/10/1981	SUPPL-24	Manufacturing (CMC)-Control	Label is not available on this site.
03/13/2009	SUPPL-23	Labeling	Label is not available on this site.
04/16/1981	SUPPL-22	Manufacturing (CMC)-Packaging	Label is not available on this site.
03/23/1981	SUPPL-21	Manufacturing (CMC)	Label is not available on this site.
01/09/1981	SUPPL-20	Labeling	Label is not available on this site.
04/28/1980	SUPPL-19	Labeling	Label is not available on this site.
12/20/1979	SUPPL-17	Labeling	Label is not available on this site.
12/20/1979	SUPPL-16	Labeling	Label is not available on this site.
01/04/1980	SUPPL-15	Manufacturing (CMC)-Control	Label is not available on this site.
03/13/2009	SUPPL-14	Labeling	Label is not available on this site.
03/13/2009	SUPPL-11	Labeling	Label is not available on this site.
02/06/1979	SUPPL-10	Labeling	Label is not available on this site.
11/21/1978	SUPPL-9	Manufacturing (CMC)	Label is not available on this site.
03/13/2009	SUPPL-8	Labeling	Label is not available on this site.
03/13/2009	SUPPL-6	Labeling	Label is not available on this site.
09/25/1974	SUPPL-4		Label is not available on this site.