Gentamicin Sulfate

Sold as Garamycin. Every FDA application for this active ingredient: 3 branded and 57 generic.

As of Nov 15, 2026, FDA lists 60 applications for Gentamicin Sulfate (sold as Garamycin), first approved Jun 19, 1970, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 19, 1970
Applications: 60
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $202K

Medicare Spending

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


Gentamicin Sulfate	Part B	$202K	-3%	37,136
Gentak	Part D	$0K	-100%	0

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

GENTAMICIN 0.1% CREAM: $0.897 per GMGeneric · +7% in a year
GENTAMICIN 0.1% OINTMENT: $0.839 per GMGeneric · -2% in a year
GENTAMICIN 0.3% EYE DROP: $0.907 per MLGeneric · +24% in a year
GENTAMICIN 80 MG/2 ML VIAL: $1.26 per MLGeneric · -24% in a year

Approvals in Japan (PMDA)

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

GentacinDrugs with a new dosage indicated for the treatment of sepsis, secondary infection of trauma, burn, and surgical wound, pneumonia, cystitis, pyelonephritis,… · MSD K.K. · Sep 13, 2013

Clinical Trials

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


Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis PlacementErectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation · Rush University Medical Center	Phase 3	Active, not recruiting	Jul 5, 2024
Intramedullary Calcium Sulfate Antibiotic DepotOpen tíbia Fracture, Osteomyelitis Tibia · Wake Forest University Health Sciences	Phase 3	Recruiting	Mar 13, 2023
Gentamicin for Junctional Epidermolysis BullosaJunctional Epidermolysis Bullosa · University of Southern California	Phase 1 / Phase 2	Recruiting	May 16, 2018

Applications

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


Mar 15, 1966	GaramycinANDA 60462	Schering	0	Discontinued
Mar 15, 1966	GaramycinANDA 60463	Schering	0	Discontinued
Jun 19, 1970	GaramycinNDA 50039	Schering	19	Discontinued
Nov 25, 1970	GaramycinNDA 50425	Schering	8	Discontinued
May 3, 1973	GaramycinANDA 61739	Schering	0	Discontinued
Oct 1, 1979	GaramycinNDA 50505 · New dosage form	Schering	8	Discontinued
May 2, 1980	U-GencinANDA 62248	Pharmacia And Upjohn	0	Discontinued
Jun 5, 1980	Gentamicin SulfateANDA 62251	Hikma	16	Marketed
Jul 2, 1980	Gentamicin SulfateANDA 62196	Sandoz	14	Marketed
Mar 3, 1981	GaramycinANDA 61716	Schering	4	Discontinued
May 15, 1981	Gentamicin SulfateANDA 62307	Padagis US	5	Marketed
Aug 20, 1981	Gentamicin SulfateANDA 62318	Watson Labs	9	Discontinued
Feb 18, 1982	Gentamicin SulfateANDA 62351	Padagis US	7	Marketed
Mar 4, 1982	Gentamicin SulfateANDA 62356	Fresenius Kabi USA	11	Discontinued
Apr 5, 1982	Gentamicin SulfateANDA 62354	Kalapharm	0	Discontinued
Sep 7, 1982	Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerANDA 62373	Baxter Hlthcare	21	Marketed
Mar 28, 1983	Gentamicin SulfateANDA 62340	Pharm Spec	0	Discontinued
May 26, 1983	Gentamicin SulfateANDA 62427	Sun Pharma Canada	19	Discontinued
Aug 4, 1983	Gentamicin SulfateANDA 62366	Fresenius Kabi USA	17	Marketed
Aug 11, 1983	Gentamicin SulfateANDA 62413	Abbott	1	Discontinued
Aug 15, 1983	Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerANDA 62414	Hospira	19	Discontinued
Aug 15, 1983	Gentamicin SulfateANDA 62420	Hospira	14	Marketed
Dec 23, 1983	Gentamicin SulfateANDA 62477	Sun Pharma Canada	9	Discontinued
Mar 30, 1984	GentacidinANDA 62480	Novartis	7	Discontinued
Jul 5, 1984	Gentamicin SulfateANDA 62531	Fougera Pharms Inc	6	Discontinued
Jul 26, 1984	GentacidinANDA 62501	Novartis	5	Discontinued
Oct 5, 1984	Gentamicin SulfateANDA 62533	Fougera Pharms Inc	5	Marketed
Oct 10, 1984	GenopticANDA 62452	Allergan	18	Discontinued
Nov 25, 1985	Gentamicin SulfateANDA 62523	Alcon Pharms Ltd	13	Discontinued
Jan 6, 1986	Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerANDA 62588	Hospira	8	Discontinued
Feb 20, 1986	Gentamicin SulfateANDA 62612	Hospira	12	Discontinued
Jan 8, 1987	Gentamicin SulfateANDA 62635	Epic Pharma LLC	12	Discontinued
Aug 28, 1987	Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerANDA 62814	B Braun	13	Discontinued
Nov 21, 1991	Gentamicin SulfateANDA 63106	Teva Parenteral	5	Discontinued
Nov 21, 1991	Gentamicin SulfateANDA 63149	Teva Parenteral	3	Discontinued
Apr 29, 1994	Gentamicin SulfateANDA 64054	Cosette Pharms Nc	0	Marketed
Apr 29, 1994	Gentamicin SulfateANDA 64056	Cosette Pharms Nc	0	Marketed
May 11, 1994	Gentamicin SulfateANDA 64048	Bausch And Lomb Inc	14	Marketed
Aug 31, 1995	Gentamicin SulfateANDA 64093	Sciegen Pharms	4	Discontinued
Oct 12, 2001	GentakANDA 64163	Pharmobedient	0	Discontinued
Jan 30, 2004	Gentamicin SulfateANDA 65121	Padagis US	1	Discontinued
Jul 30, 2004	Gentamicin SulfateANDA 65024	Sciegen Pharms	0	Marketed
Dec 31, 2018	Gentamicin SulfateANDA 209233	Encube	0	Marketed
Jan 8, 2024	Gentamicin SulfateANDA 215236	Eugia Pharma	0	Discontinued
Jan 8, 2024	Gentamicin SulfateANDA 215237	Eugia Pharma	0	Marketed
—	GentafairANDA 62444	Pharmafair	0	Discontinued
—	Gentamicin SulfateANDA 62264	Wyeth Ayerst	0	Discontinued
—	BristagenANDA 62288	Bristol	0	Discontinued
—	ApogenANDA 62289	King Pharms	0	Discontinued
—	GentamicinANDA 62325	Intl Medication	0	Discontinued
—	GentafairANDA 62440	Pharmafair	0	Discontinued
—	GentafairANDA 62443	Pharmafair	0	Discontinued
—	GentafairANDA 62458	Pharmafair	0	Discontinued
—	Gentamicin SulfateANDA 62471	Alpharma US Pharms	0	Discontinued
—	GentafairANDA 62493	Pharmafair	0	Discontinued
—	Gentamicin SulfateANDA 62496	Alpharma US Pharms	0	Discontinued
—	Gentamicin SulfateANDA 62507	Solopak	0	Discontinued
—	Gentamicin SulfateANDA 62530	Pharmaderm	0	Discontinued
—	Gentamicin SulfateANDA 62534	Pharmaderm	0	Discontinued
—	Gentamicin SulfateANDA 62932	Paco	0	Discontinued

Show all 60

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