Oxazepam

Sold as Serax. Every FDA application for this active ingredient: 1 branded and 22 generic.

As of Nov 14, 2026, FDA lists 23 applications for Oxazepam (sold as Serax), first approved Jun 4, 1965, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 4, 1965
Applications: 23
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.4M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Oxazepam	Part D	$1.4M	-29%	4,868

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

OXAZEPAM 10 MG CAPSULE: $0.722 per unitGeneric · -14% in a year
OXAZEPAM 15 MG CAPSULE: $0.835 per unitGeneric · -24% in a year
OXAZEPAM 30 MG CAPSULE: $1.44 per unitGeneric · +11% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug classSep 23, 2020 · boxed warning

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use DisorderAlcohol Use Disorder · National Institute of Mental Health (NIMH)	Phase 1	Recruiting	Jan 28, 2025

Applications

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


Jun 4, 1965	SeraxNDA 15539 · New molecular entity	Alpharma US Pharms	21	Discontinued
Jan 16, 1987	OxazepamANDA 70683	Sun Pharm Industries	12	Discontinued
Apr 21, 1987	OxazepamANDA 71494	Watson Labs	2	Discontinued
Aug 3, 1987	OxazepamANDA 70943	Ivax Sub Teva Pharms	21	Discontinued
Aug 3, 1987	OxazepamANDA 70944	Ivax Sub Teva Pharms	21	Discontinued
Aug 3, 1987	OxazepamANDA 70945	Ivax Sub Teva Pharms	24	Discontinued
Aug 10, 1987	OxazepamANDA 71026	Tp Anda Holdings	13	Marketed
Apr 14, 1988	OxazepamANDA 72253	Actavis Elizabeth	12	Marketed
Apr 19, 1988	OxazepamANDA 71756	Epic Pharma LLC	14	Marketed
Sep 28, 1990	OxazepamANDA 72952	Watson Labs Teva	5	Discontinued
Sep 28, 1990	OxazepamANDA 72953	Watson Labs	5	Discontinued
Sep 28, 1990	OxazepamANDA 72954	Watson Labs	5	Discontinued
Mar 3, 2025	OxazepamANDA 218261	Leading	0	Marketed
—	ZaxopamANDA 70640	Quantum Pharmics	1	Discontinued
—	ZaxopamANDA 70641	Quantum Pharmics	1	Discontinued
—	ZaxopamANDA 70650	Quantum Pharmics	0	Discontinued
—	OxazepamANDA 71508	Parke Davis	0	Discontinued
—	OxazepamANDA 71713	Mylan	0	Discontinued
—	OxazepamANDA 71714	Mylan	0	Discontinued
—	OxazepamANDA 71715	Mylan	0	Discontinued
—	OxazepamANDA 71955	Am Therap	0	Discontinued
—	OxazepamANDA 71956	Am Therap	0	Discontinued
—	OxazepamANDA 71957	Am Therap	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