FDA Orange Book · active-ingredient family
Busulfan
Busulfan is approved as 2 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BUSULFEX · NDA 020954
2
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUSULFEXRLD | OTSUKA PHARM | NDA 020954 | AP | Feb 04, 1999 | |
| MYLERANRLD | WAYLIS THERAP | NDA 009386 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUSULFAN | PRINSTON INC | ANDA 215235 | AP | Sep 11, 2024 | |
| BUSULFAN | EUGIA PHARMA | ANDA 215102 | — | Jun 25, 2024 | |
| BUSULFAN | MEITHEAL | ANDA 212127 | AP | Oct 23, 2020 | |
| BUSULFAN | APOTEX | ANDA 210448 | — | May 07, 2019 | |
| BUSULFAN | SHILPA | ANDA 210931 | AP | Apr 18, 2019 | |
| BUSULFAN | ACCORD HLTHCARE INC | ANDA 210148 | AP | Feb 22, 2019 | |
| BUSULFAN | NEXUS | ANDA 207794 | — | Jan 14, 2019 | |
| BUSULFAN | ARTHUR GRP | ANDA 205106 | — | Sep 21, 2018 | |
| BUSULFAN | HOSPIRA | ANDA 205672 | AP | Jul 31, 2018 | |
| BUSULFAN | PHARMOBEDIENT | ANDA 205184 | — | Jul 13, 2018 | |
| BUSULFAN | AMNEAL | ANDA 209580 | AP | Dec 18, 2017 | |
| BUSULFAN | ACTAVIS | ANDA 205139 | — | Dec 08, 2017 | |
| BUSULFAN | MYLAN INSTITUTIONAL | ANDA 208536 | AP | Nov 20, 2017 | |
| BUSULFAN | PHARMASCIENCE INC | ANDA 207050 | AP | Mar 24, 2017 | |
| BUSULFAN | AM REGENT | ANDA 202259 | — | Dec 22, 2015 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Busulfan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
