Nefazodone Hydrochloride

Sold as Serzone. Every FDA application for this active ingredient: 1 branded and 9 generic.

As of Nov 15, 2026, FDA lists 10 applications for Nefazodone Hydrochloride (sold as Serzone), first approved Dec 22, 1994, with 1 new use approved and 0 published complete response letters.

First approved: Dec 22, 1994
Applications: 10
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $1.2M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Nefazodone HCl	Part D	$1.2M	+4%	1,306

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

NEFAZODONE HCL 100 MG TABLET: $1.17 per unitGeneric · -9% in a year
NEFAZODONE HCL 200 MG TABLET: $1.33 per unitGeneric · -6% in a year

Applications

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


Dec 22, 1994	SerzoneNDA 20152 · New molecular entity	Bristol Myers Squibb	35	Discontinued
Sep 16, 2003	Nefazodone HydrochlorideANDA 76037	Teva	9	Marketed
Sep 16, 2003	Nefazodone HydrochlorideANDA 76072	Ani Pharms	2	Discontinued
Sep 16, 2003	Nefazodone HydrochlorideANDA 76073	Watson Labs	3	Discontinued
Sep 16, 2003	Nefazodone HydrochlorideANDA 76129	Aurobindo Pharma USA	2	Discontinued
Sep 16, 2003	Nefazodone HydrochlorideANDA 76302	Chartwell Rx	2	Discontinued
Sep 16, 2003	Nefazodone HydrochlorideANDA 76309	Dr Reddys Labs Inc	5	Discontinued
Sep 16, 2003	Nefazodone HydrochlorideANDA 76409	Sun Pharm Inds Ltd	4	Discontinued
—	Nefazodone HydrochlorideANDA 75763	Ivax Sub Teva Pharms	0	Discontinued
—	Nefazodone HydrochlorideANDA 76196	Roxane	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