Nystatin

Treats infections of the oral cavity caused by Candida albicans. Sold as Candex, Nilstat, Nysert, Mycostatin. Every FDA application for this active ingredient: 5 branded and 76 generic.

As of Nov 14, 2026, FDA lists 81 applications for Nystatin (sold as Candex, Nilstat, Nysert and others), first approved Apr 14, 1971, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 14, 1971
Applications: 81
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $81.2M

Medicare Spending

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


Nystatin	Part D	$59.2M	+12%	1,713,707
Nystop	Part D	$9.4M	-14%	182,311
Klayesta	Part D	$6.4M	+109%	185,986
Nyamyc	Part D	$6.1M	-36%	123,965

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

NYSTATIN 100,000 UNIT/GM CREAM: $0.165 per GMGeneric · -8% in a year
NYSTATIN 100,000 UNIT/GM OINT: $0.232 per GMGeneric · -2% in a year
NYSTATIN 100,000 UNIT/GM POWD: $0.306 per GMGeneric · -13% in a year
NYSTATIN 100,000 UNIT/ML SUSP: $0.055 per MLGeneric · -10% in a year
NYSTATIN 500,000 UNIT ORAL TAB: $0.403 per unitGeneric · +3% in a year

Clinical Trials

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


Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led ModelOral Lichen Planus, Recurrent Aphthous Stomatitis · University of Fujairah	Not applicable	Not yet recruiting	Jul 22, 2026
Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.Squamous Cell Carcinoma of the Head and Neck, Oral Mucositis · Fundacion Clinica Valle del Lili	Phase 1 / Phase 2	Not yet recruiting	Mar 13, 2025
Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against PathogensBacterial Vaginosis · Danylo Halytsky Lviv National Medical University	Phase 1	Active, not recruiting	Sep 27, 2024
A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)Gastroesophageal Cancer · Merck Sharp & Dohme LLC	Phase 3	Active, not recruiting	Apr 10, 2024
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.Oral Lichen Planus · Malmö University	Phase 2 / Phase 3	Active, not recruiting	Apr 28, 2020
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular DegenerationAge-Related Macular Degeneration · Astellas Institute for Regenerative Medicine	Phase 1	Recruiting	Jun 6, 2017

Applications

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


Jul 8, 1964	MycostatinANDA 60577	Delcor Asset Corp	0	Discontinued
Sep 8, 1964	MycostatinANDA 60578	Delcor Asset Corp	3	Discontinued
Sep 16, 1964	MycostatinANDA 60574	Delcor Asset Corp	4	Discontinued
Feb 9, 1965	MycostatinANDA 60575	Delcor Asset Corp	5	Discontinued
Apr 14, 1971	NilstatNDA 50299	Chartwell Molecules	21	Marketed
Feb 25, 1972	MycostatinANDA 61533	Delcor Asset Corp	9	Discontinued
Sep 30, 1974	KorostatinANDA 61718	Holland Rantos	0	Discontinued
May 25, 1976	NystatinANDA 61966	Cosette Pharms Nc	18	Marketed
Feb 1, 1979	NystatinANDA 62129	Fougera Pharms	5	Marketed
Dec 11, 1979	NystatinANDA 62225	Padagis US	8	Marketed
Feb 11, 1980	NystatinANDA 62176	Watson Labs	0	Discontinued
Jul 14, 1982	NystatinANDA 62349	G And W Labs Inc	15	Discontinued
Sep 23, 1982	NystatinANDA 62124	Fougera Pharms	8	Marketed
Dec 16, 1982	NystatinANDA 62402	Watson Labs	0	Discontinued
Jul 28, 1983	NystatinANDA 62457	Sun Pharma Canada	6	Discontinued
Dec 22, 1983	NilstatNDA 50576 · New dosage form	Strides Pharma Intl	1	Discontinued
Dec 22, 1983	NystatinANDA 62474	Heritage	5	Marketed
Jan 16, 1984	NystatinANDA 62506	Teva	32	Marketed
Feb 13, 1984	NystatinANDA 62472	Padagis US	3	Marketed
Jun 7, 1984	NystatinANDA 62517	Fougera Pharms Inc	6	Marketed
Jul 6, 1984	NystexANDA 62519	Savage Labs	6	Discontinued
Oct 29, 1984	NystatinANDA 62512	Pharmobedient	8	Marketed
Jan 16, 1985	NystatinANDA 62541	Pharmafair	0	Discontinued
Oct 17, 1985	NystatinANDA 62615	Odyssey Pharms	6	Discontinued
Nov 26, 1985	NystatinANDA 62524	Chartwell Rx	2	Discontinued
Nov 26, 1985	NystatinANDA 62613	Paddock LLC	9	Discontinued
Apr 9, 1987	MycostatinNDA 50619 · New dosage form	Delcor Asset Corp	4	Discontinued
Jun 18, 1987	NystatinANDA 62670	Teva	13	Discontinued
Nov 13, 1987	NystatinANDA 62840	Actavis Mid Atlantic	9	Marketed
Dec 17, 1987	NystatinANDA 62776	Cosette Pharms Nc	25	Discontinued
Feb 29, 1988	NystatinANDA 62876	Taro	5	Discontinued
Jun 13, 1988	NystatinANDA 62949	Actavis Mid Atlantic	10	Marketed
Dec 22, 1988	NystatinANDA 62838	Sun Pharm Industries	10	Discontinued
Dec 27, 1991	NystatinANDA 62832	Sciegen Pharms	7	Marketed
Jan 29, 1993	NystatinANDA 64022	Sun Pharma Canada	2	Marketed
Feb 28, 1994	NystatinANDA 64042	Pai Holdings	8	Discontinued
Sep 16, 1994	NystatinANDA 61965	Sandoz	0	Discontinued
Sep 16, 1994	NystatinANDA 62065	Sandoz	7	Discontinued
Aug 16, 1996	NystopANDA 64118	Padagis US	12	Marketed
Jun 25, 1998	NystatinANDA 64142	Vistapharm LLC	2	Discontinued
Jul 15, 2004	NystatinANDA 65203	Dr Reddys Labs SA	1	Marketed
Jul 23, 2004	NystatinANDA 65138	Lupin	0	Marketed
Dec 17, 2004	NystatinANDA 65175	Pharmobedient	1	Discontinued
May 3, 2005	NystatinANDA 65183	Upsher Smith Labs	1	Marketed
Jun 28, 2005	NystatinANDA 65148	Genus	1	Marketed
May 31, 2006	NystatinANDA 65315	Chartwell Rx	0	Discontinued
Aug 18, 2006	NystatinANDA 65321	Nesher Pharms	0	Discontinued
Jan 7, 2016	NystatinANDA 203621	Pharm Assoc	0	Marketed
May 30, 2017	NystatinANDA 208838	Lyne	0	Marketed
Jun 8, 2017	NystatinANDA 208581	Zydus Pharms	0	Marketed
Sep 26, 2017	NystatinANDA 207733	Crown Labs Inc	0	Marketed
Oct 6, 2017	NystatinANDA 209114	Cosette	1	Marketed
Apr 30, 2018	KlayestaANDA 210532	Epic Pharma LLC	0	Marketed
May 21, 2018	NystatinANDA 209082	Lyne	0	Marketed
May 25, 2018	NystatinANDA 207767	Zydus Lifesciences	0	Marketed
Jan 28, 2019	NystatinANDA 211838	Torrent	0	Marketed
Jul 24, 2019	NystatinANDA 212557	Torrent	0	Marketed
Jan 14, 2021	NystatinANDA 213826	Macleods Pharms	0	Marketed
Aug 10, 2021	NystatinANDA 213566	Macleods Pharms	0	Marketed
Mar 10, 2022	NystatinANDA 214346	Pharmazone	0	Marketed
Mar 21, 2025	NystatinANDA 219527	Aurobindo Pharma	0	Marketed
Feb 5, 2026	NystatinANDA 220367	Adaptis	0	Discontinued
—	NystatinANDA 62835	Morton Grove	0	Discontinued
—	CandexNDA 50233	Bayer Pharms	0	Discontinued
—	NysertNDA 50478	Warner Chilcott	0	Discontinued
—	MycostatinANDA 60571	Delcor Asset Corp	0	Discontinued
—	NilstatANDA 61151	Lederle	0	Discontinued
—	NilstatANDA 61325	Lederle	0	Discontinued
—	NilstatANDA 61444	Lederle	0	Discontinued
—	NilstatANDA 61445	Lederle	0	Discontinued
—	CandexANDA 61810	Bayer Pharms	0	Discontinued
—	MykinacANDA 62387	Alpharma US Pharms	0	Discontinued
—	NystatinANDA 62459	Fougera	0	Discontinued
—	NystatinANDA 62460	Pharmaderm	0	Discontinued
—	Barstatin 100ANDA 62489	Barlan	0	Discontinued
—	NystatinANDA 62502	Teva	0	Discontinued
—	NystatinANDA 62509	Quantum Pharmics	0	Discontinued
—	NystatinANDA 62518	Pharmaderm	0	Discontinued
—	NystatinANDA 62525	Quantum Pharmics	0	Discontinued
—	NystatinANDA 62571	Alpharma US Pharms	0	Discontinued
—	MykinacANDA 62731	Alpharma US Pharms	0	Discontinued

Show all 81

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