NDA 20954, held by Otsuka Pharm. Busulfan.
As of Nov 14, 2026, NDA 20954 (Busulfex), held by Otsuka Pharm, was first approved by FDA on Feb 4, 1999, with 16 approved supplements and 0 published complete response letters.
| Jan 13, 2003 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Feb 4, 1999 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Busulfex6MG/ML · injectable;injection | Busulfan | RxReference drug |
| Mar 11, 2020 | Supplement 20Labeling · Standard review | Approved | |
| Sep 28, 2018 | Supplement 18Labeling · Standard review | Approved | |
| Sep 28, 2018 | Supplement 19Labeling · Standard review | Approved | |
| Jan 24, 2018 | Supplement 17Labeling · Standard review | Approved | |
| May 19, 2016 | Supplement 16Labeling · Standard review | Approved | |
| Oct 28, 2015 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jan 16, 2015 | Supplement 14Labeling · Standard review | Approved | |
| Sep 4, 2014 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jun 23, 2011 | Supplement 9Labeling · Standard review | Approved | |
| Jun 23, 2011 | Supplement 10Labeling | Approved | |
| Apr 19, 2007 | Supplement 8Manufacturing | Approved | |
| Jan 13, 2003 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Dec 23, 2002 | Supplement 1Labeling · Standard review | Approved | |
| Nov 13, 2002 | Supplement 5Manufacturing · Priority review | Approved | |
| Apr 24, 2002 | Supplement 3Labeling · Standard review | Approved | |
| Dec 7, 1999 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Feb 4, 1999 | Original applicationNew dosage form · 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
