Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 011751
Company: APOTHECON

Products on NDA 011751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/1960	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
09/30/2002	SUPPL-99	Manufacturing (CMC)	Label is not available on this site.
08/08/1997	SUPPL-98	Manufacturing (CMC)-Formulation	Label is not available on this site.
08/08/1997	SUPPL-97	Manufacturing (CMC)	Label is not available on this site.
05/30/1997	SUPPL-95	Labeling	Label is not available on this site.
12/20/1994	SUPPL-93	Labeling	Label is not available on this site.
06/28/1991	SUPPL-92	Labeling	Label is not available on this site.
06/28/1991	SUPPL-91	Manufacturing (CMC)-Control	Label is not available on this site.
03/13/2009	SUPPL-90	Labeling	Label is not available on this site.
03/13/2009	SUPPL-89	Labeling	Label is not available on this site.
03/13/2009	SUPPL-88	Labeling	Label is not available on this site.
03/13/2009	SUPPL-87	Labeling	Label is not available on this site.
03/13/2009	SUPPL-84	Labeling	Label is not available on this site.
03/13/2009	SUPPL-82	Labeling	Label is not available on this site.
08/02/1985	SUPPL-79	Manufacturing (CMC)-Packaging	Label is not available on this site.
03/13/2009	SUPPL-77	Labeling	Label is not available on this site.
03/13/2009	SUPPL-76	Labeling	Label is not available on this site.
03/13/2009	SUPPL-65	Labeling	Label is not available on this site.
03/13/2009	SUPPL-64	Labeling	Label is not available on this site.
03/13/2009	SUPPL-61	Labeling	Label is not available on this site.
03/13/2009	SUPPL-59	Labeling	Label is not available on this site.
03/13/2009	SUPPL-58	Labeling	Label is not available on this site.
03/13/2009	SUPPL-56	Labeling	Label is not available on this site.
03/13/2009	SUPPL-55	Labeling	Label is not available on this site.
03/13/2009	SUPPL-54	Labeling	Label is not available on this site.
04/23/1979	SUPPL-52	Labeling	Label is not available on this site.
03/13/2009	SUPPL-49	Labeling	Label is not available on this site.
03/13/2009	SUPPL-48	Labeling	Label is not available on this site.
02/06/1979	SUPPL-47	Labeling	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.
03/13/2009	SUPPL-30	Labeling	Label is not available on this site.
03/13/2009	SUPPL-29	Labeling	Label is not available on this site.
03/13/2009	SUPPL-28	Labeling	Label is not available on this site.
03/13/2009	SUPPL-27	Labeling	Label is not available on this site.
03/13/2009	SUPPL-25	Labeling	Label is not available on this site.
03/13/2009	SUPPL-23	Labeling	Label is not available on this site.