Neomycin Sulfate

Sold as Mycifradin. Every FDA application for this active ingredient: 1 branded and 13 generic.

As of Nov 15, 2026, FDA lists 14 applications for Neomycin Sulfate (sold as Mycifradin), first approved Mar 13, 2009, with 0 new uses approved and 0 published complete response letters.

First approved: Mar 13, 2009
Applications: 14
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.2M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Neomycin Sulfate	Part D	$1.2M	+27%	92,168

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

NEOMYCIN 500 MG TABLET: $0.853 per unitGeneric · -2% in a year

Clinical Trials

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


Fecal Microbiota Transplantation (FMT) to Slow Biological AgingAging, Healthy, Aging and Cognitive Health · Human Biome S.A.	Not applicable	Not yet recruiting	Nov 3, 2026
Evaluation of Three Different Intra-canal MedicamentsPeriapical Healing · Minia University	Not applicable	Recruiting	Oct 23, 2026
Sebum Metabolomics and Lipidomics for Clinical ApplicationsAcne, Atopic Dermatitis · National Taiwan University Hospital	Not applicable	Not yet recruiting	Apr 24, 2026
Intestinal Microbiota Transplantation in Patients With Chronic Heart FailureChronic Heart Failure · Melana Yuzefpolskaya, MD	Phase 1	Recruiting	Mar 24, 2026
Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon SurgerySurgical Site Infection, Colon Surgery · Universität Luzern	Phase 4	Not yet recruiting	Sep 18, 2025
Intestinal Microbiome Transplant in ALSAmyotrophic Lateral Sclerosis ALS · Duke University	Phase 1 / Phase 2	Recruiting	Jun 12, 2025
Multi-omics Dissection of Gut Microbiome Engraftment During FMTRecurrent C. Difficile (rCDI), Ulcerative Colitis (UC) · Catholic University of the Sacred Heart	Not applicable	Recruiting	May 28, 2025
Evaluation of Microbiota Transplant Therapy in Patients With Alopecia AreataAlopecia Areata, Alopecia Totalis · University of Minnesota	Phase 2	Recruiting	Dec 24, 2024

Applications

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


Sep 2, 1964	Neomycin SulfateANDA 60304	Teva	17	Marketed
Oct 26, 1966	Neomycin SulfateANDA 60607	Lannett	0	Discontinued
Jan 5, 1972	Neo-RxANDA 61579	X Gen Pharms	4	Discontinued
May 23, 2002	Neo-FradinANDA 65010	X Gen Pharms	1	Discontinued
Jul 28, 2006	Neomycin SulfateANDA 65220	Amvika	1	Marketed
Mar 13, 2009	MycifradinNDA 50285	Pharmacia And Upjohn	33	Discontinued
Mar 29, 2010	Neomycin SulfateANDA 65468	Pharmobedient	2	Discontinued
Jun 10, 2016	Neomycin SulfateANDA 204435	Chartwell Molecular	2	Discontinued
—	Neomycin SulfateANDA 60365	Bristol Myers Squibb	0	Discontinued
—	Neomycin SulfateANDA 60385	Lilly	0	Discontinued
—	NeobioticANDA 60475	Pfizer	0	Discontinued
—	MycifradinANDA 60520	Pharmacia And Upjohn	0	Discontinued
—	Neomycin SulfateANDA 61586	Sandoz	0	Discontinued
—	Neomycin SulfateANDA 62173	Roxane	0	Discontinued

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