Amitriptyline Hydrochloride

Sold as Elavil. Every FDA application for this active ingredient: 2 branded and 140 generic.

As of Nov 15, 2026, FDA lists 142 applications for Amitriptyline Hydrochloride (sold as Elavil), first approved Apr 7, 1961, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 7, 1961
Applications: 142
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $54.9M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Amitriptyline HCl	Part D	$54.9M	+0%	843,014

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

AMITRIPTYLINE HCL 10 MG TAB: $0.030 per unitGeneric · -19% in a year
AMITRIPTYLINE HCL 100 MG TAB: $0.144 per unitGeneric · -19% in a year
AMITRIPTYLINE HCL 150 MG TAB: $0.292 per unitGeneric · +2% in a year
AMITRIPTYLINE HCL 25 MG TAB: $0.052 per unitGeneric · -7% in a year
AMITRIPTYLINE HCL 50 MG TAB: $0.100 per unitGeneric · +8% in a year
AMITRIPTYLINE HCL 75 MG TAB: $0.126 per unitGeneric · -3% 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

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of ErythromelalgiaAlgo Therapeutix S.A.S · designated May 27, 2020 · withdrawn

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

TryptanolDrugs with a new additional indication and a new dosage for the treatment of peripheral neuropathic pain. · Sawai Pharmaceutical Co., Ltd. · Feb 29, 2016

Clinical Trials

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


Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot StudyChronic Postsurgical Pain, Chronic Post Cancer Surgery Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre	Phase 2	Recruiting	Nov 5, 2026
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot StudyCancer Pain, Orofacial Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre	Phase 2	Recruiting	Nov 5, 2026
Acute Post-Amputation Pain Management After Combat-Related Lower Limb InjuryPostamputation Pain, Lower Limb Amputation · Kharkiv National Medical University	Not applicable	Not yet recruiting	Oct 7, 2026
Nortriptyline Compared With Amitriptyline for Migraine Prevention at SQUHMigraine · Sultan Qaboos University	Phase 4	Not yet recruiting	Oct 2, 2026
Discontinuing Psychotropic Medication Before Psychotherapy for PTSDPost-traumatic Stress Disorder (PTSD) · Academic Centre for Dentistry in Amsterdam	—	Not yet recruiting	Sep 3, 2026
Modality Choice Before and After Failure for the Treatment of Painful Diabetic NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Nephropathies · University of Michigan	Phase 4	Not yet recruiting	Aug 31, 2026
Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical AmitriptylineThermal Burn, Amitriptyline · Wright State University	Phase 1	Not yet recruiting	Jul 21, 2026
Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective TinnitusTinnitus, Subjective, Cupping Therapy · Hamad Medical Corporation	Not applicable	Not yet recruiting	Jul 6, 2026

Applications

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


Apr 7, 1961	ElavilNDA 12703 · New molecular entity	Astrazeneca	52	Discontinued
Apr 11, 1961	ElavilNDA 12704 · New dosage form	Astrazeneca	25	Discontinued
Nov 16, 1976	Amitriptyline HydrochlorideANDA 85031	Ani Pharms	37	Discontinued
Nov 19, 1976	Amitriptyline HydrochlorideANDA 85032	Ani Pharms Inc	34	Discontinued
Dec 27, 1976	EndepANDA 85303	Roche	1	Discontinued
May 10, 1977	Amitriptyline HydrochlorideANDA 85627	Mutual Pharm	23	Discontinued
Jun 21, 1977	Amitriptyline HydrochlorideANDA 85744	Mutual Pharm	16	Discontinued
Jul 11, 1977	Amitriptyline HydrochlorideANDA 85743	Mutual Pharm	17	Discontinued
Jul 11, 1977	Amitriptyline HydrochlorideANDA 85745	Mutual Pharm	23	Discontinued
Jul 13, 1977	Amitriptyline HydrochlorideANDA 85742	Mutual Pharm	21	Discontinued
Aug 2, 1977	Amitriptyline HydrochlorideANDA 85836	Teva	29	Discontinued
Sep 29, 1977	Amitriptyline HydrochlorideANDA 85944	Roxane	4	Discontinued
Sep 29, 1977	Amitriptyline HydrochlorideANDA 85945	Roxane	4	Discontinued
Oct 3, 1977	Amitriptyline HydrochlorideANDA 86002	Roxane	4	Discontinued
Oct 3, 1977	Amitriptyline HydrochlorideANDA 86003	Roxane	3	Discontinued
Oct 3, 1977	Amitriptyline HydrochlorideANDA 86004	Roxane	4	Discontinued
Oct 28, 1977	Amitriptyline HydrochlorideANDA 86090	Roxane	4	Discontinued
Nov 21, 1977	Amitriptyline HydrochlorideANDA 85970	Sandoz	36	Marketed
Nov 29, 1977	Amitriptyline HydrochlorideANDA 85968	Sandoz	41	Marketed
Jan 23, 1978	Amitriptyline HydrochlorideANDA 86143	Roxane	1	Discontinued
Jan 23, 1978	Amitriptyline HydrochlorideANDA 86144	Roxane	1	Discontinued
Jan 23, 1978	Amitriptyline HydrochlorideANDA 86145	Roxane	1	Discontinued
Jan 23, 1978	Amitriptyline HydrochlorideANDA 86146	Roxane	1	Discontinued
Jan 23, 1978	Amitriptyline HydrochlorideANDA 86147	Roxane	1	Discontinued
Jan 23, 1978	Amitriptyline HydrochlorideANDA 86148	Roxane	1	Discontinued
Apr 10, 1978	Amitriptyline HydrochlorideANDA 86009	Aurobindo Pharma USA	32	Marketed
Apr 10, 1978	Amitriptyline HydrochlorideANDA 86010	Mylan	24	Marketed
Apr 10, 1978	Amitriptyline HydrochlorideANDA 86011	Mylan	23	Marketed
Apr 26, 1978	Amitriptyline HydrochlorideANDA 86153	Mylan	20	Marketed
Apr 26, 1978	Amitriptyline HydrochlorideANDA 86158	Mylan	24	Marketed
Apr 26, 1978	Amitriptyline HydrochlorideANDA 86157	Mylan	23	Marketed
May 11, 1978	Amitriptyline HydrochlorideANDA 85815	Watson Labs	3	Discontinued
Aug 15, 1978	Amitriptyline HydrochlorideANDA 85816	Watson Labs	1	Discontinued
Aug 15, 1978	Amitriptyline HydrochlorideANDA 85817	Watson Labs	3	Discontinued
Aug 16, 1978	Amitriptyline HydrochlorideANDA 85819	Watson Labs	1	Discontinued
Sep 1, 1978	Amitriptyline HydrochlorideANDA 85820	Watson Labs	1	Discontinued
Sep 18, 1978	Amitriptyline HydrochlorideANDA 85821	Watson Labs	0	Discontinued
Oct 19, 1978	AmitidANDA 86454	Bristol Myers Squibb	0	Discontinued
Nov 18, 1981	Amitriptyline HydrochlorideANDA 85925	Halsey	0	Discontinued
Feb 1, 1982	Amitriptyline HydrochlorideANDA 87632	Vangard	1	Discontinued
Feb 5, 1982	Amitriptyline HydrochlorideANDA 87617	Vangard	1	Discontinued
Feb 8, 1982	Amitriptyline HydrochlorideANDA 87616	Vangard	1	Discontinued
Feb 8, 1982	Amitriptyline HydrochlorideANDA 87639	Vangard	1	Discontinued
Feb 10, 1982	Amitriptyline HydrochlorideANDA 87775	Usl Pharma	0	Discontinued
May 20, 1983	Amitriptyline HydrochlorideANDA 85926	Halsey	0	Discontinued
May 20, 1983	Amitriptyline HydrochlorideANDA 85927	Halsey	0	Discontinued
Mar 2, 1984	Amitriptyline HydrochlorideANDA 88620	Watson Labs	0	Discontinued
Mar 2, 1984	Amitriptyline HydrochlorideANDA 88621	Watson Labs	0	Discontinued
Mar 2, 1984	Amitriptyline HydrochlorideANDA 88622	Watson Labs	0	Discontinued
Mar 2, 1984	Amitriptyline HydrochlorideANDA 88633	Watson Labs	0	Discontinued
Mar 2, 1984	Amitriptyline HydrochlorideANDA 88634	Watson Labs	0	Discontinued
Mar 2, 1984	Amitriptyline HydrochlorideANDA 88635	Watson Labs	0	Discontinued
Sep 25, 1984	Amitriptyline HydrochlorideANDA 88699	Par Pharm	0	Discontinued
Sep 25, 1984	Amitriptyline HydrochlorideANDA 88697	Par Pharm	0	Discontinued
Sep 25, 1984	Amitriptyline HydrochlorideANDA 88698	Par Pharm	0	Discontinued
Sep 25, 1984	Amitriptyline HydrochlorideANDA 88700	Par Pharm	0	Discontinued
Sep 25, 1984	Amitriptyline HydrochlorideANDA 88701	Par Pharm	0	Discontinued
Sep 25, 1984	Amitriptyline HydrochlorideANDA 88702	Par Pharm	0	Discontinued
Sep 26, 1984	Amitriptyline HydrochlorideANDA 88883	Pliva	13	Discontinued
Sep 26, 1984	Amitriptyline HydrochlorideANDA 88884	Pliva	13	Discontinued
Sep 26, 1984	Amitriptyline HydrochlorideANDA 88886	Pliva	16	Discontinued
Sep 26, 1984	Amitriptyline HydrochlorideANDA 88888	Pliva	15	Discontinued
Sep 26, 1984	Amitriptyline HydrochlorideANDA 88887	Pliva	16	Discontinued
Sep 26, 1984	Amitriptyline HydrochlorideANDA 88885	Pliva	13	Discontinued
Feb 17, 1987	Amitriptyline HydrochlorideANDA 89423	Mutual Pharm	17	Discontinued
Jul 14, 1987	Amitriptyline HydrochlorideANDA 89402	Mutual Pharm	19	Marketed
Jul 14, 1987	Amitriptyline HydrochlorideANDA 89400	Mutual Pharm	19	Marketed
Jul 14, 1987	Amitriptyline HydrochlorideANDA 89399	Sun Pharm Inds Inc	26	Marketed
Sep 11, 1997	Amitriptyline HydrochlorideANDA 40218	Ph Health	9	Discontinued
Jun 27, 2008	Amitriptyline HydrochlorideANDA 40816	Sun Pharm Inds Inc	3	Discontinued
Jun 4, 2014	Amitriptyline HydrochlorideANDA 202446	Accord Hlthcare	3	Marketed
Oct 6, 2017	Amitriptyline HydrochlorideANDA 210086	Zydus Pharms	1	Marketed
Apr 7, 2020	Amitriptyline HydrochlorideANDA 212654	Aiping Pharm Inc	3	Marketed
Feb 19, 2021	Amitriptyline HydrochlorideANDA 213999	Mankind Pharma	2	Marketed
May 19, 2021	Amitriptyline HydrochlorideANDA 214548	Unichem	2	Marketed
Jun 6, 2022	Amitriptyline HydrochlorideANDA 216243	Breckenridge	1	Discontinued
May 1, 2023	Amitriptyline HydrochlorideANDA 215376	Rubicon Research	1	Marketed
May 19, 2023	Amitriptyline HydrochlorideANDA 217411	Rising	1	Marketed
Jun 23, 2025	Amitriptyline HydrochlorideANDA 218389	Unique Pharm	1	Marketed
Nov 5, 2026	Amitriptyline HydrochlorideANDA 219639	Cmp Dev LLC	0	Marketed
—	Amitriptyline HydrochlorideANDA 87367	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 87368	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 87369	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 87370	Lederle	0	Discontinued
—	EndepANDA 83639	Roche	0	Discontinued
—	AmitrilANDA 83937	Warner Chilcott	0	Discontinued
—	AmitrilANDA 83938	Warner Chilcott	0	Discontinued
—	AmitrilANDA 83939	Warner Chilcott	0	Discontinued
—	AmitrilANDA 84957	Warner Chilcott	0	Discontinued
—	AmitrilANDA 85093	Warner Chilcott	0	Discontinued
—	Amitriptyline HydrochlorideANDA 85594	Watson Labs	0	Discontinued
—	EndepANDA 85749	Roche	0	Discontinued
—	Amitriptyline HydrochlorideANDA 85864	Ucb Inc	0	Discontinued
—	Amitriptyline HydrochlorideANDA 85922	Halsey	0	Discontinued
—	Amitriptyline HydrochlorideANDA 85923	Halsey	0	Discontinued
—	Amitriptyline HydrochlorideANDA 85935	Ucb Inc	0	Discontinued
—	Amitriptyline HydrochlorideANDA 85936	Ucb Inc	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86745	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86746	Lederle	1	Discontinued
—	AmitrilANDA 86295	Warner Chilcott	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86335	Ucb Inc	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86336	Ucb Inc	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86337	Ucb Inc	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86747	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86610	Teva	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86743	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86744	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86853	Teva	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86854	Teva	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86857	Teva	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86859	Teva	0	Discontinued
—	Amitriptyline HydrochlorideANDA 86860	Teva	0	Discontinued
—	Amitriptyline HydrochlorideANDA 87181	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 87278	West Ward	1	Discontinued
—	Amitriptyline HydrochlorideANDA 87366	Lederle	0	Discontinued
—	Amitriptyline HydrochlorideANDA 87557	Halsey	1	Discontinued
—	Amitriptyline HydrochlorideANDA 87647	West Ward	1	Discontinued
—	Amitriptyline HydrochlorideANDA 88075	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88076	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88077	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88078	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88079	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88084	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88085	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88105	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88106	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88107	Purepac Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88421	Copley Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88422	Copley Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88423	Copley Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88424	Copley Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88425	Copley Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88426	Copley Pharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88673	Am Therap	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88674	Am Therap	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88675	Am Therap	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88672	Am Therap	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88853	Superpharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88854	Superpharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88855	Superpharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88856	Superpharm	0	Discontinued
—	Amitriptyline HydrochlorideANDA 88857	Superpharm	0	Discontinued

Show all 142

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