Cephalexin

Sold as Keflex, Keflet. Every FDA application for this active ingredient: 3 branded and 54 generic.

As of Nov 13, 2026, FDA lists 57 applications for Cephalexin (sold as Keflex, Keflet), first approved Jan 4, 1971, with 6 new uses approved and 0 published complete response letters.

First approved: Jan 4, 1971
Applications: 57
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $48.9M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Cephalexin	Part D	$48.9M	-15%	5,455,245

Clinical Trials

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

Study	Phase	Status	Posted
Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.Caffeine, Hypoxia · Liverpool John Moores University	Phase 4	Recruiting	Nov 13, 2026
Precision Management of Urinary Tract Symptoms in Older WomenUrinary Tract Infection (Diagnosis) · Megan Bradley	Phase 3	Recruiting	Jul 7, 2026
Naproxen Versus Placebo as Adjunct Treatment of CellulitisCellulitis, Skin Disease, Infectious · Ottawa Hospital Research Institute	Phase 3	Not yet recruiting	Jun 24, 2026
Self-Start Triage Model for Post-Botox® Lower Urinary Tract SymptomsOveractive Bladder · The Cleveland Clinic	Early phase 1	Recruiting	Jun 15, 2026
Extended Oral Antibiotic Prophylaxis in Diabetic Fracture PatientsFracture Lower Leg, Diabetes · Texas Tech University Health Sciences Center, El Paso	Phase 4	Recruiting	May 1, 2026
Prophylactic Antibiotics for Outpatient Urethral BulkingUrinary Tract Infections, Stress Urinary Incontinence · University of Miami	Phase 4	Recruiting	Mar 30, 2026
Nailbed Repair for Patients With Nailbed InjuriesNail Bed Injury, Nail Laceration · Stanford University	Not applicable	Recruiting	Feb 5, 2026
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract InfectionChronic Urinary Tract Infection · University College, London	Phase 2	Recruiting	Oct 2, 2025

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jan 4, 1971	KeflexNDA 50405	Pragma	98	Discontinued
Jan 4, 1971	KeflexNDA 50406 · New formulation or manufacturer	Pragma	7	Discontinued
Oct 12, 1972	KefletNDA 50440	Lilly	36	Discontinued
Apr 26, 1976	CephalexinANDA 61969	Ivax Sub Teva Pharms	16	Discontinued
Mar 27, 1978	CephalexinANDA 62117	Facta Farma	14	Discontinued
Mar 27, 1978	CephalexinANDA 62118	Facta Farma	10	Discontinued
Dec 1, 1986	KefletANDA 62745	Lilly	2	Discontinued
Feb 13, 1987	CephalexinANDA 62702	Teva	32	Marketed
Feb 13, 1987	CephalexinANDA 62703	Teva	28	Marketed
Apr 22, 1987	CephalexinANDA 62775	Barr	12	Discontinued
Apr 24, 1987	CephalexinANDA 62760	Teva	20	Discontinued
Apr 24, 1987	CephalexinANDA 62761	Teva	20	Discontinued
Jun 11, 1987	CephalexinANDA 62791	Sun Pharm Inds (In)	5	Discontinued
Jun 16, 1987	CephalexinANDA 62768	Teva	17	Discontinued
Jun 16, 1987	CephalexinANDA 62767	Teva	18	Discontinued
Jun 26, 1987	CephalexinANDA 62773	Barr	12	Discontinued
Aug 6, 1987	CephalexinANDA 62777	Barr	10	Discontinued
Aug 6, 1987	CephalexinANDA 62778	Barr	11	Discontinued
Aug 17, 1987	CephalexinANDA 62827	Barr	10	Discontinued
Aug 17, 1987	CephalexinANDA 62826	Barr	8	Discontinued
Mar 17, 1988	CephalexinANDA 62870	Stevens J	5	Discontinued
Mar 17, 1988	CephalexinANDA 62869	Stevens J	6	Discontinued
Jun 20, 1988	CephalexinANDA 62872	Yoshitomi	2	Discontinued
Jul 5, 1988	CephalexinANDA 62871	Yoshitomi	2	Discontinued
Jul 15, 1988	CephalexinANDA 62713	Ajenat Pharms	3	Marketed
Jan 12, 1989	CephalexinANDA 63024	Teva	23	Marketed
Jul 25, 1989	CephalexinANDA 62987	Apothecon	5	Discontinued
Sep 29, 1989	CephalexinANDA 63063	Apothecon	3	Discontinued
Apr 18, 1991	CephalexinANDA 62986	Apothecon	5	Discontinued
Dec 30, 1994	CephalexinANDA 63186	Apothecon	2	Discontinued
Sep 16, 1999	CephalexinANDA 65007	Sun Pharm Inds Ltd	9	Discontinued
Jul 27, 2001	CephalexinANDA 65081	Sun Pharm Inds Ltd	1	Discontinued
Sep 11, 2003	Panixine DisperdoseANDA 65100	Ranbaxy Labs Ltd	0	Discontinued
Feb 24, 2005	CephalexinANDA 65152	Chartwell Rx	1	Marketed
Jun 28, 2005	CephalexinANDA 65248	Anda Repository	2	Marketed
Aug 17, 2005	CephalexinANDA 65234	Lupin	0	Marketed
Nov 16, 2005	CephalexinANDA 65253	Aurobindo Pharma	1	Marketed
Nov 25, 2005	CephalexinANDA 65229	Lupin	1	Marketed
Jan 24, 2006	CephalexinANDA 65215	Hikma	1	Discontinued
Jul 10, 2006	CephalexinANDA 65326	Chartwell Rx	1	Discontinued
Jul 25, 2007	CephalexinANDA 65336	Yung Shin Pharm	1	Marketed
Aug 28, 2009	CephalexinANDA 65444	Hikma Pharms	0	Discontinued
Dec 20, 2010	CephalexinANDA 90836	Alkem Labs Ltd	3	Marketed
Mar 26, 2019	CephalexinANDA 210221	Alkem Labs Ltd	0	Marketed
Sep 27, 2024	CephalexinANDA 218817	Aurobindo Pharma Ltd	0	Marketed
Sep 27, 2024	CephalexinANDA 218947	Alkem Labs Ltd	0	Marketed
Jun 9, 2026	CephalexinANDA 213568	Aurobindo Pharma	0	Marketed
—	CephalexinANDA 62821	Teva	0	Discontinued
—	CephalexinANDA 62863	Vitarine	0	Discontinued
—	CephalexinANDA 62867	Teva	0	Discontinued
—	CephalexinANDA 62779	Vitarine	2	Discontinued
—	CephalexinANDA 62781	Vitarine	1	Discontinued
—	CephalexinANDA 62809	Purepac Pharm	0	Discontinued
—	CephalexinANDA 62823	Teva	0	Discontinued
—	CephalexinANDA 62873	Teva	0	Discontinued
—	CephalexinANDA 62973	Apothecon	0	Discontinued
—	CephalexinANDA 62974	Apothecon	0	Discontinued

Show all 57

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