Orange Book product · Generic (ANDA)
BUSULFAN
BUSULFAN
At a glance
Sep 21, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 21, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
BUSULFAN
Strength
6MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 205106
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUSULFAN
- 1999BUSULFEXBrand (NDA)
NDA 020954 · OTSUKA PHARM
- —MYLERANBrand (NDA)
NDA 009386 · WAYLIS THERAP
- 2024BUSULFANGeneric (ANDA)
ANDA 215235 · PRINSTON INC
- 2024BUSULFANGeneric (ANDA)
ANDA 215102 · EUGIA PHARMA
- 2020BUSULFANGeneric (ANDA)
ANDA 212127 · MEITHEAL
- 2019BUSULFANGeneric (ANDA)
ANDA 210448 · APOTEX
- 2019BUSULFANGeneric (ANDA)
ANDA 210931 · SHILPA
- 2019BUSULFANGeneric (ANDA)
ANDA 210148 · ACCORD HLTHCARE INC
- 2019BUSULFANGeneric (ANDA)
ANDA 207794 · NEXUS
- 2018BUSULFANGeneric (ANDA)
ANDA 205672 · HOSPIRA
- 2018BUSULFANGeneric (ANDA)
ANDA 205184 · PHARMOBEDIENT
- 2017BUSULFANGeneric (ANDA)
ANDA 209580 · AMNEAL
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.
