Fluphenazine Hydrochloride

Sold as Prolixin, Permitil. Every FDA application for this active ingredient: 5 branded and 36 generic.

As of Nov 15, 2026, FDA lists 41 applications for Fluphenazine Hydrochloride (sold as Prolixin, Permitil), first approved Sep 9, 1959, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 9, 1959
Applications: 41
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $23.3M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Fluphenazine HCl	Part D	$23.3M	-15%	24,027
FLUPHENAZINE HCL	Part B	$3K	New	39

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FLUPHENAZINE 1 MG TABLET: $0.237 per unitGeneric · -30% in a year
FLUPHENAZINE 10 MG TABLET: $0.390 per unitGeneric · -22% in a year
FLUPHENAZINE 2.5 MG TABLET: $0.248 per unitGeneric · -47% in a year
FLUPHENAZINE 5 MG TABLET: $0.236 per unitGeneric · -38% in a year

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 9, 1959	PermitilNDA 12034 · New molecular entity	Schering	7	Discontinued
Dec 23, 1959	ProlixinNDA 12145 · New dosage form	Apothecon	12	Discontinued
Jun 24, 1960	PermitilNDA 12419 · New dosage form	Schering	0	Discontinued
Aug 24, 1960	ProlixinNDA 11751 · New formulation or manufacturer	Apothecon	36	Discontinued
Apr 7, 1965	PermitilNDA 16008 · New dosage form	Schering	9	Discontinued
Nov 7, 1985	ProlixinANDA 70533	Apothecon	10	Discontinued
Apr 16, 1987	Fluphenazine HydrochlorideANDA 89556	Fresenius Kabi USA	9	Marketed
Oct 16, 1987	Fluphenazine HydrochlorideANDA 89585	Sandoz	14	Marketed
Oct 16, 1987	Fluphenazine HydrochlorideANDA 89586	Sandoz	16	Discontinued
Aug 12, 1988	Fluphenazine HydrochlorideANDA 89804	Prasco	14	Discontinued
Aug 25, 1988	Fluphenazine HydrochlorideANDA 89740	Lannett	15	Marketed
Aug 25, 1988	Fluphenazine HydrochlorideANDA 89742	Lannett	16	Marketed
Aug 25, 1988	Fluphenazine HydrochlorideANDA 89743	Lannett Co Inc	17	Marketed
Aug 25, 1988	Fluphenazine HydrochlorideANDA 89741	Lannett	15	Marketed
Aug 30, 1991	Fluphenazine HydrochlorideANDA 73058	Ani Pharms	10	Discontinued
Apr 29, 1993	Fluphenazine HydrochlorideANDA 81310	Ani Pharms	5	Discontinued
Aug 21, 1996	Fluphenazine HydrochlorideANDA 40146	Pharm Assoc	5	Marketed
Sep 16, 1996	Fluphenazine HydrochlorideANDA 74725	Pharm Assoc	5	Marketed
Jul 9, 2020	Fluphenazine HydrochlorideANDA 213647	Amneal	1	Marketed
Jan 7, 2021	Fluphenazine HydrochlorideANDA 214534	Dr Reddys	1	Marketed
Mar 1, 2021	Fluphenazine HydrochlorideANDA 214674	Novitium Pharma	1	Marketed
May 27, 2021	Fluphenazine HydrochlorideANDA 214552	Zydus Lifesciences	1	Marketed
Oct 20, 2021	Fluphenazine HydrochlorideANDA 215141	Chartwell Rx	1	Marketed
Apr 1, 2022	Fluphenazine HydrochlorideANDA 215848	Twi Pharms	1	Discontinued
Apr 14, 2022	Fluphenazine HydrochlorideANDA 215674	Taro	1	Marketed
Jul 15, 2022	Fluphenazine HydrochlorideANDA 216649	Apotex	1	Discontinued
Oct 24, 2022	Fluphenazine HydrochlorideANDA 213784	Upsher Smith Labs	1	Marketed
Nov 15, 2022	Fluphenazine HydrochlorideANDA 216891	Breckenridge	1	Discontinued
Jan 5, 2023	Fluphenazine HydrochlorideANDA 217410	Ajanta Pharma Ltd	1	Marketed
Aug 18, 2023	Fluphenazine HydrochlorideANDA 218055	Aurobindo Pharma Ltd	1	Marketed
Sep 11, 2023	Fluphenazine HydrochlorideANDA 217189	Msn	1	Marketed
Nov 6, 2023	Fluphenazine HydrochlorideANDA 216350	Glenmark Pharms Ltd	1	Marketed
Jan 22, 2024	Fluphenazine HydrochlorideANDA 217094	Torrent	0	Discontinued
Jun 7, 2024	Fluphenazine HydrochlorideANDA 218283	Rising	1	Marketed
Jul 23, 2024	Fluphenazine HydrochlorideANDA 218173	Alembic	1	Marketed
Nov 18, 2025	Fluphenazine HydrochlorideANDA 218769	Hetero Labs Ltd Iii	0	Marketed
—	Fluphenazine HydrochlorideANDA 88527	Watson Labs	0	Discontinued
—	Fluphenazine HydrochlorideANDA 88544	Watson Labs	0	Discontinued
—	Fluphenazine HydrochlorideANDA 88550	Watson Labs	0	Discontinued
—	Fluphenazine HydrochlorideANDA 88555	Watson Labs	0	Discontinued
—	Fluphenazine HclANDA 89800	Quad Pharms	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA