Lorazepam

Manages anxiety disorders. Sold as Ativan, Loreev Xr. Every FDA application for this active ingredient: 3 branded and 70 generic.

As of Nov 13, 2026, FDA lists 73 applications for Lorazepam (sold as Ativan, Loreev Xr), first approved Sep 30, 1977, with 1 new use approved and 0 published complete response letters.

First approved: Sep 30, 1977
Applications: 73
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $90.5M
Shortage: Current

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Lorazepam	Part D	$63.7M	+22%	1,865,605
Ativan	Part D	$23.3M	+3%	1,488
Loreev XR	Part D	$2.8M	+23%	1,086
Lorazepam Intensol	Part D	$773K	-33%	18,342
Ativan	Part B	$10K	-19%	2,638

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Lorazepam Injection	Current	May 3, 2018	Nov 9, 2026

Clinical Trials

25 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Effect of IE Glasses on MRI Patient OutcomesMRI-related Anxiety, MRI Completion Rate · Baptist Health South Florida	Not applicable	Not yet recruiting	Jun 22, 2026
Synaptic Mechanisms of Continuous Theta Burst Stimulation in DepressionMajor Depression · Mclean Hospital	Early phase 1	Recruiting	May 1, 2026
Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in ChinaAnxiety Depression, Sleep · Duke Kunshan University	Phase 4	Recruiting	Apr 27, 2026
Lorazepam for Delirium Prevention in Critically Ill Patients With High Anttila-IndexDelirium Confusional State · University Hospital, Basel, Switzerland	Phase 4	Not yet recruiting	Feb 24, 2026
Lorazepam and the Risk of Serious Adverse EventsChronic Kidney Disease (CKD) · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	—	Active, not recruiting	Sep 18, 2025
Use of VR for Diagnostic HysteroscopyHysteroscopy, Anxiety · St. Justine's Hospital	Not applicable	Recruiting	Sep 15, 2025
Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate HyperplasiaBenign Prostate Hypertrophy(BPH) · University of Manitoba	Phase 3	Not yet recruiting	Jun 12, 2025
A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell TransplantationAML (Acute Myelogenous Leukemia), Acute Lymphoid Leukemia (ALL) · Center for International Blood and Marrow Transplant Research	Phase 2	Recruiting	Mar 5, 2025

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Sep 30, 1977	AtivanNDA 17794 · New molecular entity	Bausch	28	Marketed
Jul 25, 1980	AtivanNDA 18140 · New dosage form	Hikma	35	Marketed
Dec 10, 1985	LorazepamANDA 70472	Mutual Pharm	10	Discontinued
Dec 10, 1985	LorazepamANDA 70473	Mutual Pharm	11	Discontinued
Dec 10, 1985	LorazepamANDA 70474	Mutual Pharm	10	Discontinued
Jul 24, 1986	LorazepamANDA 71110	Watson Labs	6	Discontinued
Jul 24, 1986	LorazepamANDA 71117	Watson Labs	7	Discontinued
Jul 24, 1986	LorazepamANDA 71118	Watson Labs	7	Discontinued
Mar 23, 1987	LorazepamANDA 71086	Watson Labs	4	Discontinued
Mar 23, 1987	LorazepamANDA 71087	Watson Labs	4	Discontinued
Mar 23, 1987	LorazepamANDA 71088	Watson Labs	4	Discontinued
Apr 21, 1987	LorazepamANDA 71141	Sandoz	21	Marketed
Apr 21, 1987	LorazepamANDA 71404	Sandoz	4	Marketed
Oct 13, 1987	LorazepamANDA 71591	Chartwell Rx	7	Discontinued
Jan 12, 1988	LorazepamANDA 71038	Warner Chilcott	1	Discontinued
Jan 12, 1988	LorazepamANDA 71039	Warner Chilcott	1	Discontinued
Apr 15, 1988	LorazepamANDA 71193	Sandoz	15	Discontinued
Apr 15, 1988	LorazepamANDA 71194	Sandoz	17	Discontinued
Apr 15, 1988	LorazepamANDA 71195	Sandoz	16	Discontinued
Mar 29, 1991	LorazepamANDA 72555	Tp Anda Holdings	14	Discontinued
Jun 28, 1991	Lorazepam IntensolANDA 72755	Hikma	8	Marketed
Oct 31, 1991	LorazepamANDA 72926	Watson Labs	21	Marketed
Oct 31, 1991	LorazepamANDA 72927	Watson Labs	19	Marketed
Oct 31, 1991	LorazepamANDA 72928	Watson Labs	19	Marketed
Apr 12, 1994	LorazepamANDA 74300	Hospira	6	Discontinued
Apr 12, 1994	LorazepamANDA 74243	Hospira	11	Marketed
Apr 15, 1994	LorazepamANDA 74276	Watson Labs	5	Discontinued
May 27, 1994	LorazepamANDA 74280	Hospira	3	Discontinued
May 27, 1994	LorazepamANDA 74282	Hospira	7	Discontinued
Sep 12, 1996	LorazepamANDA 74535	Pharmobedient	6	Discontinued
Sep 12, 1996	LorazepamANDA 74551	Caplin	3	Discontinued
Mar 18, 1997	LorazepamANDA 74648	Roxane	2	Discontinued
Jul 23, 1998	LorazepamANDA 74974	Epic Pharma LLC	3	Discontinued
Jul 23, 1998	LorazepamANDA 75025	Rising	5	Marketed
Sep 28, 1998	LorazepamANDA 74496	Hikma	2	Discontinued
Mar 16, 2000	LorazepamANDA 74793	Ph Health	2	Discontinued
Aug 29, 2001	LorazepamANDA 76045	Sun Pharm Inds Ltd	1	Marketed
Nov 15, 2004	LorazepamANDA 76150	Intl Medication Sys	4	Marketed
Jul 13, 2005	Lorazepam Preservative FreeANDA 77074	Bedford Labs	0	Discontinued
Jul 13, 2005	LorazepamANDA 77076	Bedford	0	Discontinued
Mar 16, 2006	LorazepamANDA 77657	Rising	5	Discontinued
May 10, 2006	LorazepamANDA 77754	Oxford Pharms	1	Marketed
Dec 13, 2006	LorazepamANDA 77396	Ani Pharms	1	Marketed
Jul 30, 2007	LorazepamANDA 78203	Leading	0	Marketed
Apr 28, 2009	LorazepamANDA 79244	Chartwell Molecular	1	Discontinued
Dec 23, 2009	LorazepamANDA 91383	Amneal Pharms	4	Marketed
Jun 15, 2010	LorazepamANDA 90260	Pharm Assoc	1	Marketed
Jun 23, 2010	LorazepamANDA 78826	Amneal Pharms	1	Discontinued
Jan 30, 2012	LorazepamANDA 200169	Hikma	0	Discontinued
Feb 19, 2013	LorazepamANDA 91407	Lupin Ltd	0	Discontinued
Apr 4, 2017	LorazepamANDA 200217	Rising	1	Discontinued
Apr 28, 2017	LorazepamANDA 200542	Rising	1	Discontinued
Dec 22, 2017	LorazepamANDA 203572	Aurobindo Pharma	2	Marketed
Aug 27, 2021	Loreev XrNDA 214826 · New dosage form	Almatica	2	Marketed
Nov 18, 2024	LorazepamANDA 217598	Fresenius Kabi USA	0	Marketed
Jul 24, 2025	LorazepamANDA 218597	Graviti Pharms	0	Marketed
—	LorazepamANDA 71434	Halsey	0	Discontinued
—	LorazepamANDA 71435	Halsey	0	Discontinued
—	LorazepamANDA 71436	Halsey	0	Discontinued
—	LorazepamANDA 70677	Par Pharm	0	Discontinued
—	LorazANDA 70200	Quantum Pharmics	0	Discontinued
—	LorazANDA 70201	Quantum Pharmics	0	Discontinued
—	LorazANDA 70202	Quantum Pharmics	0	Discontinued
—	LorazepamANDA 70539	Usl Pharma	0	Discontinued
—	LorazepamANDA 70540	Usl Pharma	0	Discontinued
—	LorazepamANDA 70675	Par Pharm	0	Discontinued
—	LorazepamANDA 70676	Par Pharm	0	Discontinued
—	LorazepamANDA 70727	Am Therap	0	Discontinued
—	LorazepamANDA 70728	Am Therap	0	Discontinued
—	LorazepamANDA 70729	Am Therap	0	Discontinued
—	LorazepamANDA 71245	Superpharm	2	Discontinued
—	LorazepamANDA 71246	Superpharm	2	Discontinued
—	LorazepamANDA 71247	Superpharm	2	Discontinued

Show all 73

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