NDA 50724, held by Leadiant Biosci Inc. Amphotericin B.
As of Nov 13, 2026, NDA 50724 (Abelcet), held by Leadiant Biosci Inc, was first approved by FDA on Nov 20, 1995, with 9 approved supplements and 0 published complete response letters.
| Oct 18, 1996 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | None posted |
| Nov 20, 1995 | Original applicationNew active ingredient · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abelcet5MG/ML · injectable, lipid complex;injection | Amphotericin B | DiscontinuedReference drug |
| Dec 23, 2013 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 6, 2013 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Sep 29, 1999 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Aug 20, 1999 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Aug 10, 1999 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jun 11, 1999 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Aug 13, 1997 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Oct 18, 1996 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | None posted |
| Sep 20, 1996 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Nov 20, 1995 | Original applicationNew active ingredient · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
