Amoxicillin

Sold as Amoxil, Larotid, Moxatag. Every FDA application for this active ingredient: 7 branded and 62 generic.

As of Nov 13, 2026, FDA lists 69 applications for Amoxicillin (sold as Amoxil, Larotid, Moxatag), first approved Jan 18, 1974, with 1 new use approved and 0 published complete response letters.

First approved: Jan 18, 1974
Applications: 69
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $32.5M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Amoxicillin	Part D	$32.5M	+11%	6,603,186

Clinical Trials

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

Study	Phase	Status	Posted
Safety of Vonoprazan-Amoxicillin Dual Therapy Versus Concomitant Quadruple Therapy for H. Pylori EradicationHELICOBACTER PYLORI INFECTIONS · Ignacio Moratorio	Phase 4	Recruiting	Nov 9, 2026
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot StudyTooth Loss and Rehabillitation, Dental Implant Failure · University of Medicine and Pharmacy at Ho Chi Minh City	Not applicable	Not yet recruiting	Nov 5, 2026
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?Elective Primary THA or TKA · Creighton University	Not applicable	Not yet recruiting	Nov 4, 2026
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate · Metagen Therapeutics, Inc.	Phase 1 / Phase 2	Recruiting	Nov 3, 2026
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.Helicobacter Infection · Nanjing First Hospital, Nanjing Medical University	Phase 3	Recruiting	Oct 29, 2026
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori InfectionHELICOBACTER PYLORI INFECTIONS · Yongquan Shi	Phase 4	Recruiting	Oct 27, 2026
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract InfectionsBronchitis, Acute, Community-acquired Pneumonia · Tampere University	Not applicable	Not yet recruiting	Oct 26, 2026
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive SurgerySurgical Wound Infection, Neck Infection · Tejs Ehlers Klug	Phase 4	Recruiting	Oct 26, 2026

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jan 18, 1974	AmoxilNDA 50459 · New molecular entity	Glaxosmithkline	0	Discontinued
Jan 18, 1974	Amoxil, LarotidNDA 50460 · New dosage form	Glaxosmithkline	0	Discontinued
Dec 9, 1974	TrimoxANDA 61886	Apothecon	3	Discontinued
Dec 10, 1974	TrimoxANDA 61885	Apothecon	3	Discontinued
Feb 9, 1976	AmoxicillinANDA 61926	Chartwell Rx	33	Marketed
Aug 3, 1978	AmoxicillinANDA 62058	Chartwell	3	Marketed
Dec 8, 1978	AmoxicillinANDA 62059	Chartwell Rx	4	Discontinued
Aug 2, 1979	AmoxilANDA 62216	US Antibiotics	22	Marketed
Nov 27, 1979	Amoxil, LarotidANDA 62226	US Antibiotics	23	Marketed
Oct 21, 1980	AmoxilNDA 50542 · New dosage form	US Antibiotics	28	Discontinued
Dec 8, 1981	PolymoxANDA 62323	Apothecon	0	Discontinued
Dec 1, 1982	Amoxicillin, Amoxicillin PediatricANDA 61931	Chartwell Rx	32	Marketed
Aug 7, 1985	AmoxicillinANDA 62528	Labs Atral	0	Discontinued
Dec 22, 1987	AmoxicillinANDA 62853	Chartwell Rx	12	Discontinued
Dec 22, 1987	AmoxicillinANDA 62854	Chartwell Rx	12	Discontinued
Feb 25, 1988	AmoxicillinANDA 62881	Strides Pharma Intl	19	Discontinued
Feb 25, 1988	AmoxicillinANDA 62884	Strides Pharma Intl	18	Discontinued
Mar 8, 1988	TrimoxANDA 62885	Apothecon	1	Discontinued
Nov 1, 1988	AmoxicillinANDA 62946	Chartwell Rx	8	Discontinued
Nov 25, 1988	AmoxicillinANDA 62927	Ph Health	17	Discontinued
Jan 6, 1989	AmoxicillinANDA 63001	Chartwell Rx	9	Discontinued
Feb 28, 1989	AmoxicillinANDA 63031	Chartwell Rx	5	Discontinued
Feb 28, 1989	AmoxicillinANDA 63030	Chartwell Rx	5	Discontinued
Mar 20, 1992	TrimoxANDA 63099	Apothecon	2	Discontinued
Dec 22, 1992	AmoxicillinANDA 64013	Chartwell Rx	40	Marketed
Sep 30, 1994	AmoxicillinANDA 64076	Sandoz	19	Marketed
Jan 29, 1996	AmoxicillinANDA 64139	Chartwell Rx	14	Discontinued
Dec 19, 1996	AmoxicillinANDA 64031	Chartwell Rx	4	Discontinued
Jul 10, 1998	AmoxilNDA 50754 · New dosage form	US Antibiotics	20	Discontinued
Apr 8, 1999	AmoxicillinANDA 65016	Sun Pharm Inds Ltd	8	Discontinued
Apr 15, 1999	AmoxilNDA 50760 · New dosage form	US Antibiotics	20	Marketed
Apr 15, 1999	AmoxilNDA 50761 · New dosage form	US Antibiotics	18	Discontinued
Dec 23, 1999	AmoxicillinANDA 65021	Sun Pharm Inds Ltd	9	Discontinued
Sep 18, 2000	AmoxicillinANDA 65056	Chartwell Rx	10	Marketed
Nov 24, 2000	AmoxicillinANDA 65059	Sun Pharm Inds Ltd	5	Discontinued
Nov 29, 2000	AmoxicillinANDA 65060	Sun Pharm Inds Ltd	5	Discontinued
Nov 29, 2002	AmoxicillinANDA 65113	Sun Pharm Inds Ltd	5	Discontinued
Dec 4, 2002	AmoxicillinANDA 65119	Chartwell Rx	6	Marketed
Aug 11, 2003	DispermoxANDA 65080	Ranbaxy Labs Ltd	0	Discontinued
Dec 4, 2003	DispermoxANDA 65159	Ranbaxy Labs Ltd	0	Discontinued
Jul 13, 2005	AmoxicillinANDA 65228	Sandoz	7	Marketed
Nov 9, 2005	AmoxicillinANDA 65271	Aurobindo	8	Marketed
Nov 9, 2005	AmoxicillinANDA 65256	Aurobindo	10	Marketed
Mar 29, 2006	AmoxicillinANDA 65255	Hikma	5	Marketed
Jun 19, 2006	AmoxicillinANDA 65322	Hikma	6	Marketed
Jun 19, 2006	AmoxicillinANDA 65325	Hikma	6	Marketed
Dec 28, 2006	AmoxicillinANDA 65334	Aurobindo	8	Marketed
Jan 17, 2007	AmoxicillinANDA 65324	Aurobindo Pharma Ltd	1	Discontinued
Feb 5, 2007	AmoxicillinANDA 65291	Hikma Pharms	3	Marketed
Mar 26, 2007	AmoxicillinANDA 65378	Sandoz	6	Marketed
Mar 26, 2007	AmoxicillinANDA 65387	Sandoz	6	Marketed
Jun 18, 2007	AmoxicillinANDA 65319	Chartwell Rx	3	Marketed
Jan 23, 2008	MoxatagNDA 50813 · New dosage form	Pragma	4	Discontinued
Jan 15, 2009	AmoxicillinANDA 65344	Chartwell Rx	4	Discontinued
Sep 15, 2014	AmoxicillinANDA 204030	Aurobindo Pharma Ltd	5	Marketed
Jun 25, 2020	AmoxicillinANDA 205274	Hikma	0	Discontinued
Jun 24, 2022	AmoxicillinANDA 207471	Micro Labs	1	Marketed
—	UtimoxANDA 62107	Parke Davis	0	Discontinued
—	PolymoxANDA 61851	Apothecon	0	Discontinued
—	AmoxicillinANDA 62067	Mylan	0	Discontinued
—	AmoxicillinANDA 62090	Mylan	0	Discontinued
—	TrimoxANDA 62098	Apothecon	0	Discontinued
—	TrimoxANDA 62099	Apothecon	0	Discontinued
—	WymoxANDA 62120	Wyeth Ayerst	0	Discontinued
—	UtimoxANDA 62127	Parke Davis	0	Discontinued
—	WymoxANDA 62131	Wyeth Ayerst	0	Discontinued
—	TrimoxANDA 62152	Apothecon	0	Discontinued
—	TrimoxANDA 62154	Apothecon	0	Discontinued
—	AmoxicillinANDA 64131	Apothecon	0	Discontinued

Show all 69

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