FDA — authorised 17 January 1995
- Application: ANDA063206
- Marketing authorisation holder: XGEN PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Abelcet in United States
FDA authorised Abelcet on 17 January 1995
Marketing authorisations
FDA — authorised 20 November 1995
- Application: NDA050724
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Local brand name: ABELCET
- Indication: INJECTABLE, LIPID COMPLEX — INJECTION
- Status: approved
FDA — authorised 23 December 1996
- Application: ANDA064141
- Marketing authorisation holder: ABBOTT
- Local brand name: AMPHOTERICIN B
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 December 2001
- Application: NDA050740
- Marketing authorisation holder: ASTELLAS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 14 December 2021
- Application: ANDA212514
- Marketing authorisation holder: SPIL
- Local brand name: AMPHOTERICIN B
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- Status: approved
FDA — authorised 17 November 2022
- Application: ANDA214010
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: AMPHOTERICIN B
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- Status: approved
FDA — authorised 2 June 2025
- Application: ANDA215354
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: AMPHOTERICIN B
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- Status: approved
FDA — authorised 30 June 2025
- Application: ANDA212967
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
Abelcet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Abelcet approved in United States?
Yes. FDA authorised it on 17 January 1995; FDA authorised it on 20 November 1995; FDA authorised it on 23 December 1996.
Who is the marketing authorisation holder for Abelcet in United States?
XGEN PHARMS holds the US marketing authorisation.