FDA — authorised 8 July 1964
- Application: ANDA060577
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
🇺🇸 Nystatin oral suspension in United States
FDA authorised Nystatin oral suspension on 8 July 1964 · 70 US adverse-event reports
Marketing authorisations
FDA — authorised 8 September 1964
- Application: ANDA060578
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 16 September 1964
- Application: ANDA060574
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1965
- Application: ANDA060575
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 25 February 1972
- Application: ANDA061533
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 October 1984
- Application: ANDA062512
- Marketing authorisation holder: PHARMOBEDIENT
- Status: supplemented
FDA — authorised 9 April 1987
- Application: NDA050619
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: PASTILLE — ORAL
- Status: approved
FDA
- Application: ANDA060571
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: OINTMENT — TOPICAL
- 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: 22 April 2025 – 22 April 2026
- Total reports: 70
Most-reported reactions
- Nausea — 10 reports (14.29%)
- Rash — 10 reports (14.29%)
- Anaemia — 8 reports (11.43%)
- Diarrhoea — 8 reports (11.43%)
- Burning Sensation — 7 reports (10%)
- Dyspnoea — 7 reports (10%)
- Fatigue — 5 reports (7.14%)
- Haemoglobin Decreased — 5 reports (7.14%)
- Hypertension — 5 reports (7.14%)
- Malaise — 5 reports (7.14%)
Other Infectious Disease approved in United States
Frequently asked questions
Is Nystatin oral suspension approved in United States?
Yes. FDA authorised it on 8 July 1964; FDA authorised it on 8 September 1964; FDA authorised it on 16 September 1964.
Who is the marketing authorisation holder for Nystatin oral suspension in United States?
DELCOR ASSET CORP holds the US marketing authorisation.