FDA — authorised 14 April 1971
- Application: NDA050299
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: NILSTAT
- Indication: SUSPENSION — ORAL
- Status: approved
🇺🇸 Nystatin 100.000 units in United States
FDA authorised Nystatin 100.000 units on 14 April 1971 · 2 US adverse-event reports
Marketing authorisations
FDA — authorised 30 September 1974
- Application: ANDA061718
- Marketing authorisation holder: HOLLAND RANTOS
- Local brand name: KOROSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 25 May 1976
- Application: ANDA061966
- Marketing authorisation holder: COSETTE
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 1 February 1979
- Application: ANDA062129
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 December 1979
- Application: ANDA062225
- Marketing authorisation holder: PADAGIS US
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 February 1980
- Application: ANDA062176
- Marketing authorisation holder: WATSON LABS
- Local brand name: NYSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 14 July 1982
- Application: ANDA062349
- Marketing authorisation holder: G AND W LABS INC
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA062124
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: NYSTATIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 16 December 1982
- Application: ANDA062402
- Marketing authorisation holder: WATSON LABS
- Local brand name: NYSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 1983
- Application: NDA050576
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: NILSTAT
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 22 December 1983
- Application: ANDA062474
- Marketing authorisation holder: HERITAGE
- Local brand name: NYSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 January 1984
- Application: ANDA062506
- Marketing authorisation holder: TEVA
- Local brand name: NYSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1984
- Application: ANDA062472
- Marketing authorisation holder: PADAGIS US
- Local brand name: NYSTATIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 7 June 1984
- Application: ANDA062517
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 July 1984
- Application: ANDA062519
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: NYSTEX
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 October 1984
- Application: ANDA062512
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 January 1985
- Application: ANDA062541
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 May 1985
- Application: ANDA060576
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOLOG-II
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 May 1985
- Application: ANDA062606
- Marketing authorisation holder: MYLAN
- Local brand name: MYCOLOG-II
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 May 1985
- Application: ANDA062367
- Marketing authorisation holder: COSETTE
- Local brand name: MYKACET
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 June 1985
- Application: ANDA060572
- Marketing authorisation holder: MYLAN
- Local brand name: MYCOLOG-II
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 20 September 1985
- Application: ANDA061954
- Marketing authorisation holder: TEVA
- Local brand name: MYCO-TRIACET II
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 October 1985
- Application: ANDA062599
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 October 1985
- Application: ANDA062597
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: MYTREX F
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 October 1985
- Application: ANDA062602
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 9 October 1985
- Application: ANDA062601
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: MYTREX F
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 17 October 1985
- Application: ANDA062615
- Marketing authorisation holder: ODYSSEY PHARMS
- Local brand name: NYSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 26 November 1985
- Application: ANDA062045
- Marketing authorisation holder: TEVA
- Local brand name: MYCO-TRIACET II
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 26 November 1985
- Application: ANDA062613
- Marketing authorisation holder: PADDOCK LLC
- Local brand name: NYSTATIN
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 26 November 1985
- Application: ANDA062524
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NYSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 1987
- Application: ANDA062733
- Marketing authorisation holder: COSETTE
- Local brand name: MYKACET
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 March 1987
- Application: ANDA062347
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 June 1987
- Application: ANDA062670
- Marketing authorisation holder: TEVA
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 December 1987
- Application: ANDA062776
- Marketing authorisation holder: COSETTE
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 December 1987
- Application: ANDA062364
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 February 1988
- Application: ANDA062876
- Marketing authorisation holder: TARO
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 June 1988
- Application: ANDA062949
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 September 1992
- Application: ANDA062065
- Marketing authorisation holder: SANDOZ
- Local brand name: NYSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 January 1993
- Application: ANDA064022
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 March 1993
- Application: ANDA063305
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 28 February 1994
- Application: ANDA064042
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 September 1994
- Application: ANDA061965
- Marketing authorisation holder: SANDOZ
- Local brand name: NYSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 25 June 1998
- Application: ANDA064142
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 July 2004
- Application: ANDA065138
- Marketing authorisation holder: LUPIN
- Local brand name: NYSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 17 December 2004
- Application: ANDA065175
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NYSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 3 May 2005
- Application: ANDA065183
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: NYSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 28 June 2005
- Application: ANDA065148
- Marketing authorisation holder: GENUS
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 May 2006
- Application: ANDA065315
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 August 2006
- Application: ANDA065321
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: NYSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 7 January 2016
- Application: ANDA203621
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 June 2016
- Application: ANDA208300
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 26 October 2016
- Application: ANDA208326
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 December 2016
- Application: ANDA206785
- Marketing authorisation holder: RISING
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 December 2016
- Application: ANDA208287
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 May 2017
- Application: ANDA208838
- Marketing authorisation holder: LYNE
- Local brand name: NYSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 8 June 2017
- Application: ANDA208581
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NYSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 4 August 2017
- Application: ANDA207217
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 14 August 2017
- Application: ANDA208479
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 September 2017
- Application: ANDA207733
- Marketing authorisation holder: CROWN LABS INC
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 October 2017
- Application: ANDA209114
- Marketing authorisation holder: COSETTE
- Local brand name: NYSTATIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA207730
- Marketing authorisation holder: CROWN LABS INC
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA207731
- Marketing authorisation holder: CROWN LABS INC
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 29 January 2018
- Application: ANDA210077
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 February 2018
- Application: ANDA209990
- Marketing authorisation holder: AMNEAL
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 30 April 2018
- Application: ANDA210532
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: KLAYESTA
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 21 May 2018
- Application: ANDA209082
- Marketing authorisation holder: LYNE
- Local brand name: NYSTATIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 31 May 2018
- Application: ANDA208205
- Marketing authorisation holder: LUPIN
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 January 2019
- Application: ANDA211838
- Marketing authorisation holder: TORRENT
- Local brand name: NYSTATIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 24 July 2019
- Application: ANDA212557
- Marketing authorisation holder: TORRENT
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 November 2019
- Application: ANDA207316
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 14 July 2020
- Application: ANDA213142
- Marketing authorisation holder: TORRENT
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 March 2021
- Application: ANDA214090
- Marketing authorisation holder: ALEMBIC
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 August 2021
- Application: ANDA213566
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 August 2021
- Application: ANDA214751
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 4 March 2022
- Application: ANDA214186
- Marketing authorisation holder: ALEMBIC
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 10 March 2022
- Application: ANDA214346
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 July 2022
- Application: ANDA214181
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 21 March 2025
- Application: ANDA219527
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NYSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 5 February 2026
- Application: ANDA220367
- Marketing authorisation holder: STERANCO HLTHCARE
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062596
- Marketing authorisation holder: PHARMADERM
- Local brand name: NYSTATIN TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062656
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA061444
- Marketing authorisation holder: LEDERLE
- Local brand name: NILSTAT
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA061445
- Marketing authorisation holder: LEDERLE
- Local brand name: NILSTAT
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA063010
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062603
- Marketing authorisation holder: PHARMADERM
- Local brand name: NYSTATIN-TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA062489
- Marketing authorisation holder: BARLAN
- Local brand name: BARSTATIN 100
- Indication: POWDER — ORAL
- Status: approved
FDA
- Application: ANDA062731
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: MYKINAC
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA062518
- Marketing authorisation holder: PHARMADERM
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062509
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: NYSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
FDA
- Application: NDA050233
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: CANDEX
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA062186
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA061325
- Marketing authorisation holder: LEDERLE
- Local brand name: NILSTAT
- Indication: TABLET — VAGINAL
- Status: approved
FDA
- Application: ANDA061151
- Marketing authorisation holder: LEDERLE
- Local brand name: NILSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062280
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA062571
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: NYSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062657
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062387
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: MYKINAC
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062525
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: NYSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062502
- Marketing authorisation holder: TEVA
- Local brand name: NYSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2
Most-reported reactions
- Myocardial Infarction — 1 report (50%)
- Pruritus Genital — 1 report (50%)
Nystatin 100.000 units in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Nystatin 100.000 units approved in United States?
Yes. FDA authorised it on 14 April 1971; FDA authorised it on 30 September 1974; FDA authorised it on 25 May 1976.
Who is the marketing authorisation holder for Nystatin 100.000 units in United States?
CHARTWELL MOLECULES holds the US marketing authorisation.