NDA 50740, held by Astellas. Amphotericin B.
As of Nov 13, 2026, NDA 50740 (Ambisome), held by Astellas, was first approved by FDA on Aug 11, 1997, with 19 approved supplements and 0 published complete response letters.
| Jun 16, 2000 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2000 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 1997 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ambisome50MG/VIAL · injectable, liposomal;injection | Amphotericin B | RxReference drug |
| Nov 4, 2024 | Supplement 37Labeling · Standard review | Approved | |
| Feb 4, 2021 | Supplement 33Labeling · Standard review | Approved | |
| May 12, 2020 | Supplement 31Labeling · Standard review | Approved | |
| Sep 16, 2014 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Mar 8, 2012 | Supplement 21Labeling · Standard review | Approved | |
| Oct 8, 2008 | Supplement 16Labeling · Standard review | Approved | |
| Sep 16, 2003 | Supplement 14Labeling · Standard review | Approved | |
| Sep 6, 2002 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jun 14, 2002 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Mar 27, 2002 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Mar 6, 2002 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Dec 4, 2001 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| May 11, 2001 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jul 13, 2000 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jun 26, 2000 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jun 16, 2000 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2000 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Feb 29, 2000 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jan 28, 2000 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 1997 | Original applicationNew active ingredient · Priority review | Approved |
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
