FDA — authorised 12 November 1964
- Application: ANDA060570
- Marketing authorisation holder: APOTHECON
- Local brand name: FUNGIZONE
- Indication: LOTION — TOPICAL
- Status: approved
🇺🇸 Amphotericin B Deoxycholate in United States
FDA authorised Amphotericin B Deoxycholate on 12 November 1964 · 202 US adverse-event reports
Marketing authorisations
FDA — authorised 13 October 1965
- Application: NDA050313
- Marketing authorisation holder: APOTHECON
- Local brand name: FUNGIZONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 7 February 1966
- Application: NDA050314
- Marketing authorisation holder: APOTHECON
- Local brand name: FUNGIZONE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 1 March 1966
- Application: ANDA060517
- Marketing authorisation holder: APOTHECON
- Local brand name: FUNGIZONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 June 1971
- Application: NDA050341
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: FUNGIZONE
- Indication: SUSPENSION — ORAL
- 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: 202
Most-reported reactions
- Drug Ineffective — 71 reports (35.15%)
- Off Label Use — 20 reports (9.9%)
- Septic Shock — 20 reports (9.9%)
- Multiple Organ Dysfunction Syndrome — 18 reports (8.91%)
- Drug Resistance — 17 reports (8.42%)
- Condition Aggravated — 14 reports (6.93%)
- Geotrichum Infection — 14 reports (6.93%)
- Immune Reconstitution Inflammatory Syndrome — 11 reports (5.45%)
- Pneumonia Fungal — 9 reports (4.46%)
- Drug Ineffective For Unapproved Indication — 8 reports (3.96%)
Other Infectious Diseases approved in United States
Frequently asked questions
Is Amphotericin B Deoxycholate approved in United States?
Yes. FDA authorised it on 12 November 1964; FDA authorised it on 13 October 1965; FDA authorised it on 7 February 1966.
Who is the marketing authorisation holder for Amphotericin B Deoxycholate in United States?
APOTHECON holds the US marketing authorisation.