Diazepam

Treats anxiety disorders Short-term treatment of anxiety symptoms. Sold as Valium, Valrelease, Dizac, Diazepam, Diastat and 3 more. Every FDA application for this active ingredient: 9 branded and 91 generic.

As of Nov 13, 2026, FDA lists 100 applications for Diazepam (sold as Valium, Valrelease, Dizac and others), first approved Nov 15, 1963, with 1 new use approved and 0 published complete response letters.

First approved: Nov 15, 1963
Applications: 100
New uses approved: 1
Complete response letters: 0
Medicare spending, 2024: $49.0M

Medicare Spending

CMS Part D and Part B, 2024, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2024	Change	Beneficiaries
Valtoco	Part D	$24.4M	+42%	9,366
Diazepam	Part D	$18.9M	-16%	928,913
Valium	Part D	$5.6M	+19%	1,490
Diazepam	Part B	$20K	-4%	1,310

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Nov 15, 1963	ValiumNDA 13263 · New molecular entity	Waylis Therap	60	Marketed
Aug 24, 1966	ValiumNDA 16087 · New dosage form	Roche	54	Discontinued
Sep 4, 1985	DiazepamANDA 70325	Mylan	15	Marketed
Sep 26, 1985	DiazepamANDA 70226	Dava Pharms Inc	12	Discontinued
Sep 26, 1985	DiazepamANDA 70227	Dava Pharms Inc	10	Discontinued
Sep 26, 1985	DiazepamANDA 70228	Ph Health	12	Discontinued
Nov 1, 1985	DiazepamANDA 70152	Barr	22	Discontinued
Nov 1, 1985	DiazepamANDA 70153	Teva Pharms	19	Discontinued
Nov 1, 1985	DiazepamANDA 70154	Barr	19	Discontinued
Dec 16, 1985	DiazepamANDA 70311	Hikma	18	Marketed
Dec 16, 1985	DiazepamANDA 70312	Hikma	16	Discontinued
Dec 16, 1985	DiazepamANDA 70313	Hikma	23	Marketed
Dec 20, 1985	DiazepamANDA 70302	Chartwell Rx	10	Discontinued
Dec 20, 1985	DiazepamANDA 70303	Chartwell Rx	9	Discontinued
Dec 20, 1985	DiazepamANDA 70304	Chartwell Rx	8	Discontinued
Feb 12, 1986	DiazepamANDA 70296	Watson Labs	13	Discontinued
Feb 25, 1986	DiazepamANDA 70462	Virtus	6	Discontinued
Feb 25, 1986	DiazepamANDA 70463	Virtus	5	Discontinued
Feb 25, 1986	DiazepamANDA 70464	Nuvo Pharm	6	Marketed
Mar 19, 1986	DiazepamANDA 70706	Actavis Elizabeth	13	Discontinued
Mar 19, 1986	DiazepamANDA 70707	Actavis Elizabeth	15	Discontinued
Aug 15, 1986	DiazepamANDA 70956	Halsey	2	Discontinued
Aug 27, 1986	DiazepamANDA 70894	Duramed Pharms Barr	2	Discontinued
Aug 27, 1986	DiazepamANDA 70895	Duramed Pharms Barr	3	Discontinued
Aug 27, 1986	DiazepamANDA 70896	Duramed Pharms Barr	3	Discontinued
Sep 19, 1986	DiazepamANDA 70781	Actavis Elizabeth	12	Discontinued
Dec 10, 1986	DiazepamANDA 71307	Ivax Sub Teva Pharms	15	Marketed
Dec 10, 1986	DiazepamANDA 71321	Ivax Sub Teva Pharms	16	Marketed
Dec 10, 1986	DiazepamANDA 71322	Ivax Sub Teva Pharms	16	Marketed
Feb 3, 1987	DiazepamANDA 71134	Dr Reddys Labs SA	13	Marketed
Feb 3, 1987	DiazepamANDA 71135	Dr Reddys Labs SA	14	Marketed
Feb 3, 1987	DiazepamANDA 71136	Dr Reddys Labs SA	16	Marketed
Apr 1, 1987	DiazepamANDA 70903	Ferndale Labs	2	Discontinued
Apr 1, 1987	DiazepamANDA 70904	Ferndale Labs	2	Discontinued
Apr 1, 1987	DiazepamANDA 70905	Ferndale Labs	2	Discontinued
Apr 3, 1987	DiazepamANDA 70928	Hikma	13	Marketed
Apr 3, 1987	Diazepam IntensolANDA 71415	Hikma	12	Marketed
Jul 17, 1987	DiazepamANDA 71308	Hikma	9	Discontinued
Jul 17, 1987	DiazepamANDA 71309	Hikma	9	Discontinued
Jul 17, 1987	DiazepamANDA 71310	Hikma	9	Discontinued
Oct 13, 1987	DiazepamANDA 71583	Hospira	11	Marketed
Oct 13, 1987	DiazepamANDA 71584	Hospira	4	Discontinued
Dec 20, 1988	DiazepamANDA 72079	Hospira	14	Marketed
Dec 5, 1990	DiazepamNDA 20124 · New dosage form	US Army	14	Discontinued
Jan 29, 1993	DiazepamANDA 72370	Watson Labs Inc	11	Discontinued
Jan 29, 1993	DiazepamANDA 72371	Marsam Pharms LLC	0	Discontinued
Jan 29, 1993	DiazepamANDA 72397	Watson Labs Inc	6	Discontinued
Aug 31, 1994	DiazepamANDA 70662	Abraxis Pharm	4	Discontinued
Jul 29, 1997	Diastat, Diastat AcudialNDA 20648 · New dosage form	Bausch	14	Marketed
Jan 3, 2000	DiazepamANDA 70357	Roxane	2	Discontinued
Jan 3, 2000	DiazepamANDA 70358	Roxane	2	Discontinued
Jan 3, 2000	DiazepamANDA 70356	Roxane	2	Discontinued
Apr 15, 2004	DiazepamANDA 76815	Parenta Pharms	0	Discontinued
Mar 31, 2006	DiazepamANDA 77749	Strides Pharma Intl	2	Discontinued
Apr 14, 2014	DiazepamANDA 204433	Chartwell Molecular	4	Marketed
Jun 24, 2016	DiazepamANDA 206477	Chartwell Molecular	2	Marketed
Mar 18, 2019	DiazepamANDA 210363	Regcon Holdings	7	Marketed
Dec 26, 2019	DiazepamANDA 211998	Regcon Holdings	6	Marketed
Jan 10, 2020	ValtocoNDA 211635 · New dosage form	Neurelis Inc	5	Marketed
Nov 10, 2022	DiazepamANDA 214745	Fresenius Kabi USA	0	Marketed
May 30, 2023	DiazepamANDA 91076	Novel Labs Inc	1	Marketed
Dec 14, 2023	DiazepamANDA 217843	Aurobindo Pharma Ltd	0	Marketed
Apr 25, 2024	DiazepamANDA 218450	Alembic	0	Marketed
Jul 18, 2024	DiazepamANDA 218422	Dr Reddys	0	Marketed
Dec 31, 2024	DiazepamANDA 217178	Long Grove Pharms	0	Marketed
May 19, 2025	DiazepamANDA 216422	Galenicum Hlth	0	Marketed
Nov 14, 2025	DiazepamANDA 217468	Navinta LLC	0	Marketed
Jul 27, 2026	DiazepamANDA 220365	Lupin	0	Marketed
Jul 28, 2026	DiazepamANDA 219882	Baxter Hlthcare Corp	0	Marketed
—	ValreleaseNDA 18179	Roche	0	Discontinued
—	DizacNDA 19287	Pharmacia And Upjohn	0	Discontinued
—	DiazepamANDA 70360	Ivax Sub Teva Pharms	0	Discontinued
—	DiazepamANDA 70209	Warner Chilcott	0	Discontinued
—	DiazepamANDA 70210	Warner Chilcott	0	Discontinued
—	DiazepamANDA 70222	Warner Chilcott	0	Discontinued
—	DiazepamANDA 70361	Ivax Sub Teva Pharms	0	Discontinued
—	DiazepamANDA 70362	Ivax Sub Teva Pharms	0	Discontinued
—	Q-PamANDA 70423	Quantum Pharmics	0	Discontinued
—	Q-PamANDA 70424	Quantum Pharmics	2	Discontinued
—	Q-PamANDA 70425	Quantum Pharmics	2	Discontinued
—	DiazepamANDA 70456	Watson Labs	0	Discontinued
—	DiazepamANDA 70457	Watson Labs	0	Discontinued
—	DiazepamANDA 70458	Watson Labs	0	Discontinued
—	DiazepamANDA 70776	Pioneer Pharms	0	Discontinued
—	DiazepamANDA 70787	Pioneer Pharms	0	Discontinued
—	DiazepamANDA 70788	Pioneer Pharms	0	Discontinued
—	DiazepamANDA 70911	Watson Labs	0	Discontinued
—	DiazepamANDA 70912	Watson Labs	0	Discontinued
—	DiazepamANDA 70930	Watson Labs	0	Discontinued
—	DiazepamANDA 70987	Halsey	0	Discontinued
—	DiazepamANDA 70996	Halsey	0	Discontinued
—	DiazepamANDA 71613	Warner Chilcott	0	Discontinued
—	DiazepamANDA 71614	Warner Chilcott	0	Discontinued
—	DiazepamANDA 72402	Martec USA LLC	0	Discontinued
—	Q-PamANDA 72431	Quantum Pharmics	0	Discontinued
—	Q-PamANDA 72432	Quantum Pharmics	0	Discontinued
—	Q-PamANDA 72433	Quantum Pharmics	0	Discontinued
—	LibervantNDA 212641	Aquestive	0	Discontinued
—	LibervantNDA 218623	Aquestive	0	Discontinued
—	DiazepamANDA 219320	Padagis Israel Pharma Ltd	0	Discontinued

Show all 100

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. Drugs@FDA